Trial Outcomes & Findings for New Era Study: Treatment With Multi Drug Class (MDC) HAART in HIV Infected Patients (NCT NCT00908544)
NCT ID: NCT00908544
Last Updated: 2019-08-28
Results Overview
The primary outcome measure (i.e. achievement of 'eradication') is a combined endpoint including cell-associated proviral DNA and plasma HIV RNA and is defined as undetectable cell-associated HIV DNA (copies per 10exp6 PBMC (peripheral blood mononuclear cells) and per 10exp6 CD4 cells) for at least 2 years (measurement by the French ANRS Group) combined with plasma viral load \< 50 copies/ml for at least 5 years and undetectable plasma viral load (HIV RNA \< 1 copy/ml, 1-copy assay) for at least 2 years.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Screening, month -3 (= pre-baseline only for CHI-patients), baseline, months 1, 3, 6 and then every 6 months until month 84
Results posted on
2019-08-28
Participant Flow
Overall 47 patients signed informed consent, of which 42 participated in the study; five patients turned out to be screening failures due to nonfulfillment of the eligibility criteria (tropism test showed X4 tropism in three patients or Western blot bands \>2 in two patients).
Participant milestones
| Measure |
CHI-patients
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
CHI-patients
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Relocation abroad
|
1
|
1
|
|
Overall Study
Unable to visit sutdy center
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
21 Participants
n=22 Participants
|
41 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=42 Participants
|
|
Age, Continuous
|
43.3 years
n=20 Participants
|
40.2 years
n=22 Participants
|
41.0 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
1 Participants
n=22 Participants
|
7 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants
|
21 Participants
n=22 Participants
|
35 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
20 Participants
n=20 Participants
|
22 Participants
n=22 Participants
|
42 Participants
n=42 Participants
|
|
HIV DNA in PBMC (peripheral blood mononuclear cells)
|
2.5 log copies/10^6 PBMC
n=19 Participants • One Patient of CHI-Group had no HIV DNA measurement.
|
3.6 log copies/10^6 PBMC
n=22 Participants • One Patient of CHI-Group had no HIV DNA measurement.
|
3 log copies/10^6 PBMC
n=41 Participants • One Patient of CHI-Group had no HIV DNA measurement.
|
|
HIV DNA in CD4+T cells
|
3 log copies/10^6 CD4+T cells
n=19 Participants • One Patient of CHI-Group had no HIV DNA measurement.
|
4.4 log copies/10^6 CD4+T cells
n=22 Participants • One Patient of CHI-Group had no HIV DNA measurement.
|
3.6 log copies/10^6 CD4+T cells
n=41 Participants • One Patient of CHI-Group had no HIV DNA measurement.
|
|
HIV RNA in Plasma
|
0.3 log copies/ml
n=18 Participants • Two Patients of CHI-Group had no single copy measurement.
|
6.2 log copies/ml
n=22 Participants • Two Patients of CHI-Group had no single copy measurement.
|
NA log copies/ml
n=40 Participants • Two Patients of CHI-Group had no single copy measurement.
|
|
Absolute CD4+T cells
|
763 cells/µl
n=20 Participants
|
485 cells/µl
n=22 Participants
|
570 cells/µl
n=42 Participants
|
|
Relative CD4+T cells
|
33 percent
n=20 Participants
|
24 percent
n=22 Participants
|
28 percent
n=42 Participants
|
|
CD4+T/CD8+T ratio
|
0.9 ratio
n=20 Participants • One Patient had no measurement of CD8+T cells .
|
0.4 ratio
n=21 Participants • One Patient had no measurement of CD8+T cells .
|
0.6 ratio
n=41 Participants • One Patient had no measurement of CD8+T cells .
|
|
Absolute CD8+T cells
|
864 cells/µl
n=20 Participants • One Patient had no measurement of CD8+T cells.
|
1117 cells/µl
n=21 Participants • One Patient had no measurement of CD8+T cells.
|
975 cells/µl
n=41 Participants • One Patient had no measurement of CD8+T cells.
|
|
Relative CD8+T cells
|
39 percent
n=20 Participants
|
55 percent
n=22 Participants
|
46 percent
n=42 Participants
|
|
Absolute CD8+/CD38+ cells
|
104 cells/µl
n=15 Participants • Not all patients had a value for this measurement.
|
872 cells/µl
n=14 Participants • Not all patients had a value for this measurement.
|
204 cells/µl
n=29 Participants • Not all patients had a value for this measurement.
|
|
Relative CD8+/CD38+ cells
|
14 percent
n=15 Participants • Not all patients had a value for this measurement.
|
89.9 percent
n=14 Participants • Not all patients had a value for this measurement.
|
33 percent
n=29 Participants • Not all patients had a value for this measurement.
|
PRIMARY outcome
Timeframe: Screening, month -3 (= pre-baseline only for CHI-patients), baseline, months 1, 3, 6 and then every 6 months until month 84Population: The efficacy dataset is based on patients who were enrolled in the study, received at least one dose of study drugs and met the inclusion criteria (N=42 patients; efficacy population).
The primary outcome measure (i.e. achievement of 'eradication') is a combined endpoint including cell-associated proviral DNA and plasma HIV RNA and is defined as undetectable cell-associated HIV DNA (copies per 10exp6 PBMC (peripheral blood mononuclear cells) and per 10exp6 CD4 cells) for at least 2 years (measurement by the French ANRS Group) combined with plasma viral load \< 50 copies/ml for at least 5 years and undetectable plasma viral load (HIV RNA \< 1 copy/ml, 1-copy assay) for at least 2 years.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Combined Endpoint Including HIV RNA and HIV DNA
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Change from baseline at months 36 and 84Population: Data of 42 patients (Efficacy set) at month 36 and 84
Mean change (CI=95% Confidence Intervall) in HIV DNA copies/10exp6 PBMC (= peripheral blood mononuclear cells) from baseline, to evaluate the decay rates of latently infected cell reservoir.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Mean Change in HIV DNA in PBMC (Month 36 and Month 84)
Month 36
|
0.2 log copies/10^6 PBMC
Interval 0.0 to 0.4
|
-1.4 log copies/10^6 PBMC
Interval -1.7 to -1.1
|
|
Mean Change in HIV DNA in PBMC (Month 36 and Month 84)
Month 84
|
0.1 log copies/10^6 PBMC
Interval -0.1 to 0.3
|
-1.3 log copies/10^6 PBMC
Interval -1.6 to -1.0
|
SECONDARY outcome
Timeframe: Change from baseline at months 36 and 84Population: Data of 42 patients (Efficacy set) at month 36 and 84
Mean change (CI=95% Confidence Intervall) in HIV DNA copies/10exp6 CD4+T cells from baseline, to evaluate the decay rates of latently infected cell reservoir.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Mean Change in HIV DNA in CD4+T Cells (Month 36 and Month 84)
Month 36
|
0.2 log copies/10^6 PBMC
Interval 0.0 to 0.4
|
-1.7 log copies/10^6 PBMC
Interval -2.0 to -1.5
|
|
Mean Change in HIV DNA in CD4+T Cells (Month 36 and Month 84)
Month 84
|
0.2 log copies/10^6 PBMC
Interval 0.0 to 0.3
|
-1.7 log copies/10^6 PBMC
Interval -2.0 to -1.4
|
SECONDARY outcome
Timeframe: Baseline and at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Percentage of patients with Plasma HIV RNA \<50 copies/ml at baseline and during follow-up
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
HIV RNA <50 Copies/ml (Proportion)
Baseline
|
20 Participants
|
0 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month1
|
18 Participants
|
0 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 3
|
20 Participants
|
12 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 6
|
20 Participants
|
17 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 12
|
20 Participants
|
18 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 18
|
20 Participants
|
19 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 24
|
19 Participants
|
19 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 30
|
19 Participants
|
18 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 36
|
19 Participants
|
18 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 42
|
18 Participants
|
18 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 48
|
17 Participants
|
17 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 54
|
16 Participants
|
17 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 60
|
15 Participants
|
17 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 66
|
15 Participants
|
16 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 72
|
15 Participants
|
14 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 78
|
14 Participants
|
15 Participants
|
|
HIV RNA <50 Copies/ml (Proportion)
Month 84
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Change from baseline at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median Change from baseline (IQR, interquartile range) in HIV DNA copies/10exp6 PBMC (= peripheral blood mononuclear cells), to evaluate the decay rates of latently infected cell reservoir.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Median Change in HIV DNA in PBMC Over Time
Baseline
|
0 log copies/10^6 PBMC
Interval 0.0 to 0.0
|
0 log copies/10^6 PBMC
Interval 0.0 to 0.0
|
|
Median Change in HIV DNA in PBMC Over Time
Month 1
|
0.1 log copies/10^6 PBMC
Interval -0.2 to 0.2
|
-0.5 log copies/10^6 PBMC
Interval -0.7 to -0.2
|
|
Median Change in HIV DNA in PBMC Over Time
Month 3
|
0.1 log copies/10^6 PBMC
Interval -0.3 to 0.4
|
-0.8 log copies/10^6 PBMC
Interval -1.1 to -0.5
|
|
Median Change in HIV DNA in PBMC Over Time
Month 6
|
0.1 log copies/10^6 PBMC
Interval -0.2 to 0.3
|
-1.0 log copies/10^6 PBMC
Interval -1.3 to -0.7
|
|
Median Change in HIV DNA in PBMC Over Time
Month 12
|
0.1 log copies/10^6 PBMC
Interval -0.4 to 0.2
|
-1.3 log copies/10^6 PBMC
Interval -1.5 to -0.9
|
|
Median Change in HIV DNA in PBMC Over Time
Month 18
|
0.1 log copies/10^6 PBMC
Interval -0.2 to 0.3
|
-1.3 log copies/10^6 PBMC
Interval -1.6 to -1.0
|
|
Median Change in HIV DNA in PBMC Over Time
Month 24
|
0.2 log copies/10^6 PBMC
Interval -0.1 to 0.4
|
-1.4 log copies/10^6 PBMC
Interval -1.7 to -1.2
|
|
Median Change in HIV DNA in PBMC Over Time
Month 30
|
0.1 log copies/10^6 PBMC
Interval -0.1 to 0.4
|
-1.5 log copies/10^6 PBMC
Interval -1.7 to -1.0
|
|
Median Change in HIV DNA in PBMC Over Time
Month 36
|
0.2 log copies/10^6 PBMC
Interval -0.1 to 0.4
|
-1.4 log copies/10^6 PBMC
Interval -1.8 to -1.0
|
|
Median Change in HIV DNA in PBMC Over Time
Month 42
|
0.1 log copies/10^6 PBMC
Interval 0.1 to 0.3
|
-1.4 log copies/10^6 PBMC
Interval -1.9 to -1.1
|
|
Median Change in HIV DNA in PBMC Over Time
Month 48
|
0.2 log copies/10^6 PBMC
Interval 0.0 to 0.4
|
-1.6 log copies/10^6 PBMC
Interval -1.7 to -1.4
|
|
Median Change in HIV DNA in PBMC Over Time
Month 54
|
0.2 log copies/10^6 PBMC
Interval 0.0 to 0.4
|
-1.5 log copies/10^6 PBMC
Interval -1.8 to -1.1
|
|
Median Change in HIV DNA in PBMC Over Time
Month 60
|
0.1 log copies/10^6 PBMC
Interval 0.0 to 0.4
|
-1.6 log copies/10^6 PBMC
Interval -1.7 to -1.2
|
|
Median Change in HIV DNA in PBMC Over Time
Month 66
|
0.1 log copies/10^6 PBMC
Interval 0.0 to 0.4
|
-1.5 log copies/10^6 PBMC
Interval -2.0 to -1.0
|
|
Median Change in HIV DNA in PBMC Over Time
Month 72
|
0.2 log copies/10^6 PBMC
Interval -0.1 to 0.4
|
-1.5 log copies/10^6 PBMC
Interval -1.7 to -1.3
|
|
Median Change in HIV DNA in PBMC Over Time
Month 78
|
0.2 log copies/10^6 PBMC
Interval 0.0 to 0.6
|
-1.6 log copies/10^6 PBMC
Interval -2.2 to -0.9
|
|
Median Change in HIV DNA in PBMC Over Time
Month 84
|
0.0 log copies/10^6 PBMC
Interval -0.1 to 0.4
|
-1.4 log copies/10^6 PBMC
Interval -1.8 to -0.8
|
SECONDARY outcome
Timeframe: Change from baseline at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median Change from baseline (IQR, interquartile range) in HIV DNA in CD4+T cells, to evaluate the decay rates of latently infected cell reservoir.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Baseline
|
0.0 log copies/10^6 CD4+T cells
Interval 0.0 to 0.0
|
0.0 log copies/10^6 CD4+T cells
Interval 0.0 to 0.0
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 1
|
0.1 log copies/10^6 CD4+T cells
Interval -0.2 to 0.3
|
-0.7 log copies/10^6 CD4+T cells
Interval -0.9 to -0.4
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 3
|
0.1 log copies/10^6 CD4+T cells
Interval -0.3 to 0.4
|
-1.1 log copies/10^6 CD4+T cells
Interval -1.3 to -0.8
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 6
|
0.1 log copies/10^6 CD4+T cells
Interval -0.2 to 0.4
|
-1.3 log copies/10^6 CD4+T cells
Interval -1.6 to -0.9
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 12
|
0.1 log copies/10^6 CD4+T cells
Interval -0.3 to 0.2
|
-1.6 log copies/10^6 CD4+T cells
Interval -1.8 to -1.2
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 18
|
0.1 log copies/10^6 CD4+T cells
Interval -0.1 to 0.3
|
-1.6 log copies/10^6 CD4+T cells
Interval -1.8 to -1.3
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 24
|
0.3 log copies/10^6 CD4+T cells
Interval 0.1 to 0.4
|
-1.7 log copies/10^6 CD4+T cells
Interval -2.0 to -1.5
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 30
|
0.2 log copies/10^6 CD4+T cells
Interval -0.1 to 0.3
|
-1.7 log copies/10^6 CD4+T cells
Interval -2.0 to -1.3
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 36
|
0.1 log copies/10^6 CD4+T cells
Interval 0.0 to 0.4
|
-1.7 log copies/10^6 CD4+T cells
Interval -2.1 to -1.3
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 42
|
0.1 log copies/10^6 CD4+T cells
Interval 0.1 to 0.3
|
-1.7 log copies/10^6 CD4+T cells
Interval -2.0 to -1.5
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 48
|
0.2 log copies/10^6 CD4+T cells
Interval 0.1 to 0.3
|
-1.9 log copies/10^6 CD4+T cells
Interval -2.1 to -1.5
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 54
|
0.2 log copies/10^6 CD4+T cells
Interval 0.0 to 0.4
|
-1.7 log copies/10^6 CD4+T cells
Interval -2.1 to -1.5
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 60
|
0.1 log copies/10^6 CD4+T cells
Interval 0.0 to 0.4
|
-1.8 log copies/10^6 CD4+T cells
Interval -1.9 to -1.6
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 66
|
0.1 log copies/10^6 CD4+T cells
Interval 0.0 to 0.4
|
-1.7 log copies/10^6 CD4+T cells
Interval -2.3 to -1.5
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 72
|
0.2 log copies/10^6 CD4+T cells
Interval 0.0 to 0.3
|
-1.8 log copies/10^6 CD4+T cells
Interval -2.1 to -1.6
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 78
|
0.2 log copies/10^6 CD4+T cells
Interval 0.1 to 0.5
|
-2.0 log copies/10^6 CD4+T cells
Interval -2.4 to -1.5
|
|
Median Change in HIV DNA in CD4+T Cells Over Time
Month 84
|
0.1 log copies/10^6 CD4+T cells
Interval -0.1 to 0.4
|
-1.7 log copies/10^6 CD4+T cells
Interval -2.2 to -1.4
|
SECONDARY outcome
Timeframe: Change from baseline at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median Change from baseline (IQR, interquartile range) in CD4+T cells/µl.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Median Change in CD4+T Cells Over Time
Baseline
|
0 cells/µl
Interval 0.0 to 0.0
|
0 cells/µl
Interval 0.0 to 0.0
|
|
Median Change in CD4+T Cells Over Time
Month 1
|
10 cells/µl
Interval -54.0 to 159.0
|
272.0 cells/µl
Interval 158.0 to 413.0
|
|
Median Change in CD4+T Cells Over Time
Month 3
|
22 cells/µl
Interval -45.0 to 109.0
|
425.0 cells/µl
Interval 173.0 to 506.0
|
|
Median Change in CD4+T Cells Over Time
Month 6
|
51.5 cells/µl
Interval -71.5 to 111.0
|
344.0 cells/µl
Interval 169.0 to 566.0
|
|
Median Change in CD4+T Cells Over Time
Month 12
|
17 cells/µl
Interval -89.0 to 103.5
|
496.0 cells/µl
Interval 222.0 to 619.0
|
|
Median Change in CD4+T Cells Over Time
Month 18
|
75.5 cells/µl
Interval -3.0 to 190.5
|
447.0 cells/µl
Interval 220.0 to 692.0
|
|
Median Change in CD4+T Cells Over Time
Month 24
|
52 cells/µl
Interval -39.5 to 116.5
|
423.0 cells/µl
Interval 239.5 to 792.5
|
|
Median Change in CD4+T Cells Over Time
Month 30
|
80 cells/µl
Interval -37.0 to 132.0
|
420.0 cells/µl
Interval 224.0 to 751.0
|
|
Median Change in CD4+T Cells Over Time
Month 36
|
45 cells/µl
Interval -19.0 to 150.0
|
395.5 cells/µl
Interval 192.0 to 678.0
|
|
Median Change in CD4+T Cells Over Time
Month 42
|
36.5 cells/µl
Interval -41.0 to 148.0
|
365.0 cells/µl
Interval 228.0 to 523.0
|
|
Median Change in CD4+T Cells Over Time
Month 48
|
48.5 cells/µl
Interval 10.0 to 128.0
|
404.0 cells/µl
Interval 254.0 to 723.0
|
|
Median Change in CD4+T Cells Over Time
Month 54
|
80 cells/µl
Interval -122.0 to 162.0
|
484.0 cells/µl
Interval 302.0 to 646.0
|
|
Median Change in CD4+T Cells Over Time
Month 60
|
60 cells/µl
Interval -78.0 to 207.0
|
383.0 cells/µl
Interval 263.0 to 724.0
|
|
Median Change in CD4+T Cells Over Time
Month 66
|
70 cells/µl
Interval -87.0 to 141.0
|
413.0 cells/µl
Interval 287.0 to 565.0
|
|
Median Change in CD4+T Cells Over Time
Month 72
|
99 cells/µl
Interval -40.0 to 215.0
|
476.5 cells/µl
Interval 356.0 to 641.5
|
|
Median Change in CD4+T Cells Over Time
Month 78
|
32 cells/µl
Interval -55.0 to 275.0
|
389.0 cells/µl
Interval 184.0 to 647.0
|
|
Median Change in CD4+T Cells Over Time
Month 84
|
49 cells/µl
Interval -142.0 to 180.0
|
457.0 cells/µl
Interval 242.0 to 578.0
|
SECONDARY outcome
Timeframe: Change from baseline at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median Change from baseline (IQR, interquartile range) in relative CD4+T cells/µl.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Median Change in Relative CD4+T Cells Over Time
Baseline
|
0 percentage of Lymphocytes
Interval 0.0 to 0.0
|
0 percentage of Lymphocytes
Interval 0.0 to 0.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 1
|
-1.0 percentage of Lymphocytes
Interval -3.0 to 0.0
|
13.5 percentage of Lymphocytes
Interval 9.0 to 17.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 3
|
-1.8 percentage of Lymphocytes
Interval -3.0 to 0.8
|
14.0 percentage of Lymphocytes
Interval 9.0 to 19.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 6
|
-1.5 percentage of Lymphocytes
Interval -3.5 to 0.8
|
18.5 percentage of Lymphocytes
Interval 10.0 to 23.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 12
|
-1.3 percentage of Lymphocytes
Interval -4.5 to 1.0
|
17.5 percentage of Lymphocytes
Interval 11.0 to 25.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 18
|
-2.0 percentage of Lymphocytes
Interval -6.0 to 0.0
|
18.0 percentage of Lymphocytes
Interval 13.0 to 23.5
|
|
Median Change in Relative CD4+T Cells Over Time
Month 24
|
-2.5 percentage of Lymphocytes
Interval -4.5 to 1.8
|
18.5 percentage of Lymphocytes
Interval 14.0 to 24.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 30
|
-1.6 percentage of Lymphocytes
Interval -4.0 to 0.0
|
16.0 percentage of Lymphocytes
Interval 13.0 to 27.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 36
|
-0.6 percentage of Lymphocytes
Interval -4.0 to 2.0
|
19.0 percentage of Lymphocytes
Interval 13.0 to 25.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 42
|
-0.5 percentage of Lymphocytes
Interval -5.0 to 3.0
|
18.5 percentage of Lymphocytes
Interval 12.0 to 25.6
|
|
Median Change in Relative CD4+T Cells Over Time
Month 48
|
-0.5 percentage of Lymphocytes
Interval -5.0 to 2.0
|
17.0 percentage of Lymphocytes
Interval 10.0 to 27.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 54
|
0.5 percentage of Lymphocytes
Interval -6.7 to 2.0
|
20.0 percentage of Lymphocytes
Interval 13.0 to 27.1
|
|
Median Change in Relative CD4+T Cells Over Time
Month 60
|
2.0 percentage of Lymphocytes
Interval -3.0 to 4.0
|
18.0 percentage of Lymphocytes
Interval 12.0 to 26.0
|
|
Median Change in Relative CD4+T Cells Over Time
Month 66
|
1.0 percentage of Lymphocytes
Interval -5.0 to 4.0
|
17.0 percentage of Lymphocytes
Interval 12.0 to 26.9
|
|
Median Change in Relative CD4+T Cells Over Time
Month 72
|
0.0 percentage of Lymphocytes
Interval -3.0 to 7.0
|
18.2 percentage of Lymphocytes
Interval 11.0 to 25.5
|
|
Median Change in Relative CD4+T Cells Over Time
Month 78
|
0.0 percentage of Lymphocytes
Interval -5.0 to 3.0
|
20.0 percentage of Lymphocytes
Interval 15.0 to 24.7
|
|
Median Change in Relative CD4+T Cells Over Time
Month 84
|
0.0 percentage of Lymphocytes
Interval -6.1 to 5.0
|
22.0 percentage of Lymphocytes
Interval 11.0 to 31.0
|
SECONDARY outcome
Timeframe: Change form Baseline at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median change in CD4+/ CD8+ ratio at baseline (IQR, interquartile range) and during follow-up
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Median Change in CD4+/CD8+ Ratio Over Time
Baseline
|
0 ratio
Interval 0.0 to 0.0
|
0.0 ratio
Interval 0.0 to 0.0
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 1
|
-0.0 ratio
Interval -0.2 to 0.0
|
0.5 ratio
Interval 0.3 to 0.8
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 3
|
-0.1 ratio
Interval -0.2 to 0.0
|
0.5 ratio
Interval 0.4 to 1.0
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 6
|
-0.1 ratio
Interval -0.1 to 0.0
|
0.7 ratio
Interval 0.6 to 1.0
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 12
|
-0.1 ratio
Interval -0.2 to 0.1
|
0.8 ratio
Interval 0.7 to 1.1
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 18
|
-0.1 ratio
Interval -0.3 to 0.0
|
0.8 ratio
Interval 0.8 to 1.1
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 24
|
-0.1 ratio
Interval -0.2 to 0.0
|
0.9 ratio
Interval 0.8 to 1.3
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 30
|
-0.1 ratio
Interval -0.3 to 0.0
|
0.8 ratio
Interval 0.7 to 1.2
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 36
|
-0.0 ratio
Interval -0.3 to 0.1
|
1.0 ratio
Interval 0.8 to 1.2
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 42
|
-0.1 ratio
Interval -0.2 to 0.0
|
1.0 ratio
Interval 0.7 to 1.2
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 48
|
-0.0 ratio
Interval -0.1 to 0.1
|
0.9 ratio
Interval 0.7 to 1.2
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 54
|
0.0 ratio
Interval -0.1 to 0.1
|
1.1 ratio
Interval 0.8 to 1.2
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 60
|
0.1 ratio
Interval -0.1 to 0.3
|
0.9 ratio
Interval 0.8 to 1.4
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 66
|
0.1 ratio
Interval -0.1 to 0.1
|
0.9 ratio
Interval 0.7 to 1.2
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 72
|
0 ratio
Interval -0.2 to 0.3
|
0.8 ratio
Interval 0.6 to 1.4
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 78
|
0 ratio
Interval -0.1 to 0.1
|
0.9 ratio
Interval 0.8 to 1.0
|
|
Median Change in CD4+/CD8+ Ratio Over Time
Month 84
|
0.1 ratio
Interval -0.2 to 0.1
|
0.9 ratio
Interval 0.7 to 1.8
|
SECONDARY outcome
Timeframe: Change from baseline at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median Change from baseline (IQR, interquartile range) in CD8+T cells/µl.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Median Change in CD8+T Cells Over Time
Baseline
|
0 cells/µl
Interval 0.0 to 0.0
|
0 cells/µl
Interval 0.0 to 0.0
|
|
Median Change in CD8+T Cells Over Time
Month 1
|
64.0 cells/µl
Interval -63.0 to 213.0
|
-405.0 cells/µl
Interval -822.0 to -43.0
|
|
Median Change in CD8+T Cells Over Time
Month 3
|
114.5 cells/µl
Interval -24.0 to 236.5
|
-375.0 cells/µl
Interval -1021.0 to -42.0
|
|
Median Change in CD8+T Cells Over Time
Month 6
|
141.0 cells/µl
Interval -32.0 to 215.0
|
-505.0 cells/µl
Interval -726.0 to -153.0
|
|
Median Change in CD8+T Cells Over Time
Month 12
|
32.0 cells/µl
Interval -118.5 to 238.0
|
-394.0 cells/µl
Interval -880.0 to -249.0
|
|
Median Change in CD8+T Cells Over Time
Month 18
|
224.0 cells/µl
Interval 41.5 to 455.0
|
-377.0 cells/µl
Interval -863.0 to -216.0
|
|
Median Change in CD8+T Cells Over Time
Month 24
|
167.0 cells/µl
Interval 3.0 to 357.0
|
-376.0 cells/µl
Interval -881.0 to -249.0
|
|
Median Change in CD8+T Cells Over Time
Month 30
|
220.0 cells/µl
Interval -49.0 to 420.0
|
-406.0 cells/µl
Interval -1007.0 to -196.0
|
|
Median Change in CD8+T Cells Over Time
Month 36
|
170.0 cells/µl
Interval 41.0 to 350.0
|
-456.0 cells/µl
Interval -826.0 to -310.0
|
|
Median Change in CD8+T Cells Over Time
Month 42
|
170.0 cells/µl
Interval -22.0 to 298.0
|
-460.5 cells/µl
Interval -1022.5 to -207.0
|
|
Median Change in CD8+T Cells Over Time
Month 48
|
80.5 cells/µl
Interval 21.0 to 261.0
|
-562.0 cells/µl
Interval -1182.5 to -98.5
|
|
Median Change in CD8+T Cells Over Time
Month 54
|
88.5 cells/µl
Interval -140.0 to 246.0
|
-507.0 cells/µl
Interval -1220.0 to -233.5
|
|
Median Change in CD8+T Cells Over Time
Month 60
|
123.0 cells/µl
Interval -237.0 to 325.0
|
-418.0 cells/µl
Interval -1305.0 to -252.0
|
|
Median Change in CD8+T Cells Over Time
Month 66
|
33.0 cells/µl
Interval -40.0 to 520.0
|
-467.5 cells/µl
Interval -1271.5 to -267.5
|
|
Median Change in CD8+T Cells Over Time
Month 72
|
123.0 cells/µl
Interval -54.0 to 291.0
|
-446.0 cells/µl
Interval -1237.0 to -97.5
|
|
Median Change in CD8+T Cells Over Time
Month 78
|
212.5 cells/µl
Interval 0.0 to 500.0
|
-494.0 cells/µl
Interval -1769.0 to -147.0
|
|
Median Change in CD8+T Cells Over Time
Month 84
|
35.0 cells/µl
Interval -161.0 to 143.0
|
-443.0 cells/µl
Interval -1670.0 to -185.0
|
SECONDARY outcome
Timeframe: Change from baseline at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median Change from baseline (IQR, interquartile range) in CD8+CD38+T cells/µl.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Median Change in CD8+CD38+T Cells Over Time
Month 36
|
11.0 cells/µl
Interval -32.0 to 73.0
|
-1077.0 cells/µl
Interval -2170.0 to -500.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Baseline
|
0 cells/µl
Interval 0.0 to 0.0
|
0 cells/µl
Interval 0.0 to 0.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 1
|
19.0 cells/µl
Interval 0.0 to 61.0
|
-488.0 cells/µl
Interval -757.0 to -192.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 3
|
51.9 cells/µl
Interval -1.0 to 114.0
|
-776.5 cells/µl
Interval -1726.5 to -451.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 6
|
24.0 cells/µl
Interval 3.0 to 97.0
|
-646.5 cells/µl
Interval -1474.0 to -484.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 12
|
32.0 cells/µl
Interval -3.0 to 51.0
|
-897.0 cells/µl
Interval -1478.0 to -583.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 18
|
50.5 cells/µl
Interval -17.0 to 125.0
|
-744.0 cells/µl
Interval -1394.0 to -464.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 24
|
2.0 cells/µl
Interval -33.0 to 49.0
|
-786.0 cells/µl
Interval -2086.0 to -456.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 30
|
4.0 cells/µl
Interval -36.0 to 64.0
|
-772.0 cells/µl
Interval -2154.0 to -467.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 42
|
-15.0 cells/µl
Interval -48.0 to 5.0
|
-726.0 cells/µl
Interval -1429.0 to -467.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 48
|
-2.0 cells/µl
Interval -53.0 to 243.0
|
-1070.0 cells/µl
Interval -2149.0 to -468.2
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 54
|
-10.0 cells/µl
Interval -62.0 to 72.0
|
-729.0 cells/µl
Interval -1446.0 to -466.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 60
|
-13.0 cells/µl
Interval -42.0 to 115.0
|
-752.0 cells/µl
Interval -1401.0 to -452.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 66
|
-22.1 cells/µl
Interval -71.0 to 72.0
|
-777.0 cells/µl
Interval -1431.0 to -469.0
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 72
|
3.5 cells/µl
Interval -57.0 to 44.0
|
-810.0 cells/µl
Interval -1438.0 to -485.9
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 78
|
31.0 cells/µl
Interval -73.0 to 77.0
|
-730.0 cells/µl
Interval -1523.0 to -474.2
|
|
Median Change in CD8+CD38+T Cells Over Time
Month 84
|
-22.5 cells/µl
Interval -82.0 to 17.9
|
-1201.5 cells/µl
Interval -2454.0 to -621.0
|
SECONDARY outcome
Timeframe: Baseline and at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Absolute HIV DNA in PBMC (= peripheral blood mononuclear cells) from baseline (Median; IQR, interquartile range), to quantify the cell-associated latently infected reservoir size by visit and treatment Group.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Absolute HIV DNA in PBMC
Baseline
|
2.5 log copies/10^6 PBMC
Interval 2.0 to 2.7
|
3.6 log copies/10^6 PBMC
Interval 3.5 to 3.8
|
|
Absolute HIV DNA in PBMC
Month 1
|
2.4 log copies/10^6 PBMC
Interval 2.2 to 2.7
|
3.1 log copies/10^6 PBMC
Interval 2.9 to 3.5
|
|
Absolute HIV DNA in PBMC
Month 3
|
2.6 log copies/10^6 PBMC
Interval 2.2 to 2.7
|
2.7 log copies/10^6 PBMC
Interval 2.6 to 3.1
|
|
Absolute HIV DNA in PBMC
Month 6
|
2.6 log copies/10^6 PBMC
Interval 2.3 to 2.7
|
2.5 log copies/10^6 PBMC
Interval 2.3 to 2.8
|
|
Absolute HIV DNA in PBMC
Month 12
|
2.4 log copies/10^6 PBMC
Interval 2.2 to 2.6
|
2.2 log copies/10^6 PBMC
Interval 2.0 to 2.7
|
|
Absolute HIV DNA in PBMC
Month 18
|
2.6 log copies/10^6 PBMC
Interval 2.3 to 2.8
|
2.2 log copies/10^6 PBMC
Interval 2.0 to 2.6
|
|
Absolute HIV DNA in PBMC
Month 24
|
2.6 log copies/10^6 PBMC
Interval 2.4 to 2.9
|
2.1 log copies/10^6 PBMC
Interval 1.9 to 2.3
|
|
Absolute HIV DNA in PBMC
Month 30
|
2.7 log copies/10^6 PBMC
Interval 2.2 to 2.8
|
2.2 log copies/10^6 PBMC
Interval 1.9 to 2.5
|
|
Absolute HIV DNA in PBMC
Month 36
|
2.7 log copies/10^6 PBMC
Interval 2.5 to 2.8
|
2.2 log copies/10^6 PBMC
Interval 1.9 to 2.3
|
|
Absolute HIV DNA in PBMC
Month 42
|
2.6 log copies/10^6 PBMC
Interval 2.4 to 2.8
|
2.0 log copies/10^6 PBMC
Interval 1.7 to 2.4
|
|
Absolute HIV DNA in PBMC
Month 48
|
2.6 log copies/10^6 PBMC
Interval 2.4 to 2.8
|
2.1 log copies/10^6 PBMC
Interval 1.8 to 2.1
|
|
Absolute HIV DNA in PBMC
Month 54
|
2.6 log copies/10^6 PBMC
Interval 2.4 to 2.6
|
2.1 log copies/10^6 PBMC
Interval 2.0 to 2.2
|
|
Absolute HIV DNA in PBMC
Month 60
|
2.5 log copies/10^6 PBMC
Interval 2.3 to 2.8
|
2.1 log copies/10^6 PBMC
Interval 1.9 to 2.2
|
|
Absolute HIV DNA in PBMC
Month 66
|
2.6 log copies/10^6 PBMC
Interval 2.4 to 2.8
|
1.9 log copies/10^6 PBMC
Interval 1.7 to 2.2
|
|
Absolute HIV DNA in PBMC
Month 72
|
2.6 log copies/10^6 PBMC
Interval 2.4 to 2.8
|
1.9 log copies/10^6 PBMC
Interval 1.8 to 2.2
|
|
Absolute HIV DNA in PBMC
Month 78
|
2.6 log copies/10^6 PBMC
Interval 2.4 to 2.8
|
2.0 log copies/10^6 PBMC
Interval 1.7 to 2.6
|
|
Absolute HIV DNA in PBMC
Month 84
|
2.4 log copies/10^6 PBMC
Interval 2.4 to 2.8
|
2.3 log copies/10^6 PBMC
Interval 2.0 to 2.6
|
SECONDARY outcome
Timeframe: Baseline and at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Absolute HIV DNA in CD4+T cells from baseline (Median; IQR, interquartile range), to quantify the cell-associated latently infected reservoir size by visit and treatment Group.
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Absolute HIV DNA in CD4+T Cells
Baseline
|
3.0 log copies/10^6 CD4+T cells
Interval 2.6 to 3.3
|
4.4 log copies/10^6 CD4+T cells
Interval 4.1 to 4.6
|
|
Absolute HIV DNA in CD4+T Cells
Month1
|
3.0 log copies/10^6 CD4+T cells
Interval 2.8 to 3.4
|
3.6 log copies/10^6 CD4+T cells
Interval 3.3 to 4.0
|
|
Absolute HIV DNA in CD4+T Cells
Month 3
|
3.1 log copies/10^6 CD4+T cells
Interval 2.9 to 3.3
|
3.2 log copies/10^6 CD4+T cells
Interval 3.0 to 3.6
|
|
Absolute HIV DNA in CD4+T Cells
Month 6
|
3.1 log copies/10^6 CD4+T cells
Interval 2.7 to 3.2
|
3.0 log copies/10^6 CD4+T cells
Interval 2.8 to 3.2
|
|
Absolute HIV DNA in CD4+T Cells
Month 12
|
3.0 log copies/10^6 CD4+T cells
Interval 2.8 to 3.2
|
2.6 log copies/10^6 CD4+T cells
Interval 2.5 to 3.1
|
|
Absolute HIV DNA in CD4+T Cells
Month 18
|
3.2 log copies/10^6 CD4+T cells
Interval 2.9 to 3.3
|
2.7 log copies/10^6 CD4+T cells
Interval 2.3 to 3.0
|
|
Absolute HIV DNA in CD4+T Cells
Month 24
|
3.3 log copies/10^6 CD4+T cells
Interval 3.0 to 3.5
|
2.6 log copies/10^6 CD4+T cells
Interval 2.3 to 2.8
|
|
Absolute HIV DNA in CD4+T Cells
Month 30
|
3.2 log copies/10^6 CD4+T cells
Interval 2.8 to 3.3
|
2.6 log copies/10^6 CD4+T cells
Interval 2.4 to 2.9
|
|
Absolute HIV DNA in CD4+T Cells
Month 36
|
3.2 log copies/10^6 CD4+T cells
Interval 3.0 to 3.4
|
2.7 log copies/10^6 CD4+T cells
Interval 2.4 to 2.8
|
|
Absolute HIV DNA in CD4+T Cells
Month 42
|
3.2 log copies/10^6 CD4+T cells
Interval 2.9 to 3.4
|
2.5 log copies/10^6 CD4+T cells
Interval 2.1 to 2.8
|
|
Absolute HIV DNA in CD4+T Cells
Month 48
|
3.2 log copies/10^6 CD4+T cells
Interval 3.0 to 3.3
|
2.5 log copies/10^6 CD4+T cells
Interval 2.4 to 2.7
|
|
Absolute HIV DNA in CD4+T Cells
Month 54
|
3.1 log copies/10^6 CD4+T cells
Interval 2.9 to 3.2
|
2.5 log copies/10^6 CD4+T cells
Interval 2.4 to 2.7
|
|
Absolute HIV DNA in CD4+T Cells
Month 60
|
3.1 log copies/10^6 CD4+T cells
Interval 2.8 to 3.4
|
2.5 log copies/10^6 CD4+T cells
Interval 2.3 to 2.7
|
|
Absolute HIV DNA in CD4+T Cells
Month 66
|
3.3 log copies/10^6 CD4+T cells
Interval 3.0 to 3.4
|
2.3 log copies/10^6 CD4+T cells
Interval 2.2 to 2.7
|
|
Absolute HIV DNA in CD4+T Cells
Month 72
|
3.1 log copies/10^6 CD4+T cells
Interval 2.9 to 3.4
|
2.4 log copies/10^6 CD4+T cells
Interval 2.2 to 2.7
|
|
Absolute HIV DNA in CD4+T Cells
Month 78
|
3.3 log copies/10^6 CD4+T cells
Interval 3.1 to 3.4
|
2.6 log copies/10^6 CD4+T cells
Interval 2.2 to 3.1
|
|
Absolute HIV DNA in CD4+T Cells
Month 84
|
3.1 log copies/10^6 CD4+T cells
Interval 2.9 to 3.4
|
2.7 log copies/10^6 CD4+T cells
Interval 2.3 to 3.1
|
SECONDARY outcome
Timeframe: Baseline and at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median CD4+T cells/µl at baseline (IQR, interquartile range) and during follow-up
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Absolute CD4+T Cells
Baseline
|
762.5 cells/µl
Interval 554.5 to 1065.0
|
484.5 cells/µl
Interval 393.0 to 577.0
|
|
Absolute CD4+T Cells
Month 1
|
653.0 cells/µl
Interval 534.0 to 1098.0
|
796.5 cells/µl
Interval 654.0 to 915.0
|
|
Absolute CD4+T Cells
Month 3
|
801.5 cells/µl
Interval 596.5 to 919.5
|
801.0 cells/µl
Interval 599.0 to 1116.0
|
|
Absolute CD4+T Cells
Month 6
|
798.0 cells/µl
Interval 588.5 to 975.5
|
854.5 cells/µl
Interval 685.0 to 983.0
|
|
Absolute CD4+T Cells
Month 12
|
749.0 cells/µl
Interval 567.0 to 920.5
|
943.5 cells/µl
Interval 688.0 to 1071.0
|
|
Absolute CD4+T Cells
Month 18
|
815.5 cells/µl
Interval 615.0 to 1200.5
|
981.5 cells/µl
Interval 666.0 to 1175.5
|
|
Absolute CD4+T Cells
Month 24
|
766.5 cells/µl
Interval 593.5 to 1041.5
|
927.5 cells/µl
Interval 721.0 to 1303.0
|
|
Absolute CD4+T Cells
Month 30
|
703.0 cells/µl
Interval 537.0 to 1110.0
|
840.0 cells/µl
Interval 641.0 to 1208.0
|
|
Absolute CD4+T Cells
Month 36
|
827.0 cells/µl
Interval 565.0 to 1145.0
|
915.5 cells/µl
Interval 638.0 to 1179.0
|
|
Absolute CD4+T Cells
Month 42
|
721.5 cells/µl
Interval 590.0 to 997.0
|
827.5 cells/µl
Interval 708.0 to 1157.0
|
|
Absolute CD4+T Cells
Month 48
|
822.0 cells/µl
Interval 589.0 to 1123.0
|
945.0 cells/µl
Interval 606.0 to 1169.0
|
|
Absolute CD4+T Cells
Month 54
|
879.5 cells/µl
Interval 570.0 to 927.0
|
880.0 cells/µl
Interval 658.0 to 1210.0
|
|
Absolute CD4+T Cells
Month 60
|
880.0 cells/µl
Interval 744.0 to 1021.0
|
877.0 cells/µl
Interval 722.0 to 1139.0
|
|
Absolute CD4+T Cells
Month 66
|
749.0 cells/µl
Interval 620.0 to 1014.0
|
977.0 cells/µl
Interval 685.0 to 1133.0
|
|
Absolute CD4+T Cells
Month 72
|
843.0 cells/µl
Interval 629.0 to 1052.0
|
940.0 cells/µl
Interval 806.5 to 1169.0
|
|
Absolute CD4+T Cells
Month 78
|
798.0 cells/µl
Interval 618.0 to 940.0
|
802.0 cells/µl
Interval 577.0 to 1112.0
|
|
Absolute CD4+T Cells
Month 84
|
733.0 cells/µl
Interval 545.0 to 964.0
|
938.0 cells/µl
Interval 739.0 to 1164.0
|
SECONDARY outcome
Timeframe: Baseline and at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median relative CD4+T cells/µl at baseline (IQR, interquartile range) and during follow-up
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Relative CD4+T Cells
Baseline
|
32.5 percentage of Lymphocytes
Interval 28.5 to 43.5
|
24.0 percentage of Lymphocytes
Interval 17.0 to 27.0
|
|
Relative CD4+T Cells
Month 1
|
32.0 percentage of Lymphocytes
Interval 28.0 to 41.0
|
34.0 percentage of Lymphocytes
Interval 32.0 to 40.0
|
|
Relative CD4+T Cells
Month 3
|
31.0 percentage of Lymphocytes
Interval 28.0 to 41.0
|
35.5 percentage of Lymphocytes
Interval 31.0 to 42.0
|
|
Relative CD4+T Cells
Month 6
|
35.0 percentage of Lymphocytes
Interval 25.5 to 40.1
|
38.5 percentage of Lymphocytes
Interval 36.0 to 45.0
|
|
Relative CD4+T Cells
Month 12
|
30.5 percentage of Lymphocytes
Interval 26.0 to 40.0
|
40.0 percentage of Lymphocytes
Interval 38.0 to 43.0
|
|
Relative CD4+T Cells
Month 18
|
31.0 percentage of Lymphocytes
Interval 26.5 to 38.0
|
40.0 percentage of Lymphocytes
Interval 37.5 to 44.0
|
|
Relative CD4+T Cells
Month 24
|
30.0 percentage of Lymphocytes
Interval 26.5 to 39.5
|
40.0 percentage of Lymphocytes
Interval 37.0 to 45.5
|
|
Relative CD4+T Cells
Month 30
|
31.5 percentage of Lymphocytes
Interval 29.0 to 42.0
|
40.0 percentage of Lymphocytes
Interval 37.0 to 43.0
|
|
Relative CD4+T Cells
Month 36
|
33.0 percentage of Lymphocytes
Interval 28.0 to 43.6
|
41.0 percentage of Lymphocytes
Interval 38.0 to 46.0
|
|
Relative CD4+T Cells
Month 42
|
32.0 percentage of Lymphocytes
Interval 26.0 to 40.0
|
41.0 percentage of Lymphocytes
Interval 38.0 to 47.0
|
|
Relative CD4+T Cells
Month 48
|
33.5 percentage of Lymphocytes
Interval 26.0 to 39.0
|
39.0 percentage of Lymphocytes
Interval 36.9 to 45.0
|
|
Relative CD4+T Cells
Month 54
|
33.0 percentage of Lymphocytes
Interval 28.0 to 43.0
|
42.0 percentage of Lymphocytes
Interval 38.0 to 46.0
|
|
Relative CD4+T Cells
Month 60
|
34.0 percentage of Lymphocytes
Interval 27.0 to 42.0
|
40.7 percentage of Lymphocytes
Interval 40.0 to 44.0
|
|
Relative CD4+T Cells
Month 66
|
31.0 percentage of Lymphocytes
Interval 24.0 to 35.0
|
40.0 percentage of Lymphocytes
Interval 38.0 to 46.0
|
|
Relative CD4+T Cells
Month 72
|
35.0 percentage of Lymphocytes
Interval 23.0 to 40.0
|
41.5 percentage of Lymphocytes
Interval 37.0 to 45.5
|
|
Relative CD4+T Cells
Month 78
|
31.5 percentage of Lymphocytes
Interval 22.0 to 34.0
|
40.0 percentage of Lymphocytes
Interval 37.0 to 47.0
|
|
Relative CD4+T Cells
Month 84
|
32.0 percentage of Lymphocytes
Interval 24.0 to 39.0
|
43.0 percentage of Lymphocytes
Interval 36.6 to 48.0
|
SECONDARY outcome
Timeframe: Baseline and at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median CD4+/CD8+ ratio at baseline (IQR, interquartile range) and during follow-up
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
CD4+/CD8+ Ratio
Baseline
|
0.9 ratio
Interval 0.6 to 1.3
|
0.4 ratio
Interval 0.3 to 0.6
|
|
CD4+/CD8+ Ratio
Month 1
|
0.9 ratio
Interval 0.6 to 1.2
|
1.0 ratio
Interval 0.7 to 1.2
|
|
CD4+/CD8+ Ratio
Month 3
|
0.8 ratio
Interval 0.6 to 1.1
|
1.0 ratio
Interval 0.8 to 1.7
|
|
CD4+/CD8+ Ratio
Month 6
|
0.8 ratio
Interval 0.6 to 1.1
|
1.2 ratio
Interval 1.0 to 1.6
|
|
CD4+/CD8+ Ratio
Month 12
|
0.7 ratio
Interval 0.6 to 1.1
|
1.3 ratio
Interval 1.2 to 1.8
|
|
CD4+/CD8+ Ratio
Month 18
|
0.7 ratio
Interval 0.6 to 1.0
|
1.3 ratio
Interval 1.1 to 1.8
|
|
CD4+/CD8+ Ratio
Month 24
|
0.8 ratio
Interval 0.6 to 1.0
|
1.5 ratio
Interval 1.1 to 1.8
|
|
CD4+/CD8+ Ratio
Month 30
|
0.7 ratio
Interval 0.5 to 1.2
|
1.3 ratio
Interval 1.1 to 1.8
|
|
CD4+/CD8+ Ratio
Month 36
|
0.8 ratio
Interval 0.6 to 1.1
|
1.3 ratio
Interval 1.1 to 1.9
|
|
CD4+/CD8+ Ratio
Month 42
|
0.8 ratio
Interval 0.5 to 1.1
|
1.3 ratio
Interval 1.1 to 1.9
|
|
CD4+/CD8+ Ratio
Month 48
|
0.8 ratio
Interval 0.6 to 1.1
|
1.5 ratio
Interval 1.1 to 1.8
|
|
CD4+/CD8+ Ratio
Month 54
|
0.9 ratio
Interval 0.7 to 1.4
|
1.5 ratio
Interval 1.1 to 2.0
|
|
CD4+/CD8+ Ratio
Month 60
|
0.9 ratio
Interval 0.6 to 1.3
|
1.4 ratio
Interval 1.1 to 1.8
|
|
CD4+/CD8+ Ratio
Month 66
|
0.9 ratio
Interval 0.5 to 1.0
|
1.3 ratio
Interval 1.2 to 1.8
|
|
CD4+/CD8+ Ratio
Month 72
|
0.8 ratio
Interval 0.5 to 1.2
|
1.5 ratio
Interval 1.1 to 1.8
|
|
CD4+/CD8+ Ratio
Month 78
|
0.7 ratio
Interval 0.5 to 1.0
|
1.4 ratio
Interval 1.0 to 1.8
|
|
CD4+/CD8+ Ratio
Month 84
|
0.7 ratio
Interval 0.5 to 1.0
|
1.4 ratio
Interval 1.0 to 2.1
|
SECONDARY outcome
Timeframe: Baseline and at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median CD8+T cells/µl at baseline (IQR, interquartile range) and during follow-up
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Absolute CD8+T Cells
Baseline
|
864.0 cells/µl
Interval 782.0 to 1132.0
|
1117.0 cells/µl
Interval 836.0 to 1615.0
|
|
Absolute CD8+T Cells
Month 1
|
949.0 cells/µl
Interval 640.0 to 1220.0
|
806.0 cells/µl
Interval 544.0 to 1014.0
|
|
Absolute CD8+T Cells
Month 3
|
904.0 cells/µl
Interval 841.5 to 1320.0
|
768.5 cells/µl
Interval 567.0 to 1147.0
|
|
Absolute CD8+T Cells
Month 6
|
980.0 cells/µl
Interval 744.0 to 1233.0
|
705.0 cells/µl
Interval 512.0 to 951.0
|
|
Absolute CD8+T Cells
Month 12
|
1031.0 cells/µl
Interval 649.5 to 1249.5
|
721.5 cells/µl
Interval 483.0 to 897.0
|
|
Absolute CD8+T Cells
Month 18
|
1193.5 cells/µl
Interval 893.0 to 1465.5
|
692.0 cells/µl
Interval 508.5 to 934.0
|
|
Absolute CD8+T Cells
Month 24
|
1133.5 cells/µl
Interval 889.0 to 1320.0
|
684.0 cells/µl
Interval 528.0 to 937.5
|
|
Absolute CD8+T Cells
Month 30
|
1103.0 cells/µl
Interval 725.0 to 1468.0
|
677.0 cells/µl
Interval 488.0 to 936.0
|
|
Absolute CD8+T Cells
Month 36
|
1010.0 cells/µl
Interval 858.0 to 1330.0
|
589.0 cells/µl
Interval 466.0 to 851.0
|
|
Absolute CD8+T Cells
Month 42
|
1066.0 cells/µl
Interval 881.0 to 1363.0
|
630.0 cells/µl
Interval 543.0 to 710.0
|
|
Absolute CD8+T Cells
Month 48
|
975.0 cells/µl
Interval 709.0 to 1255.0
|
669.0 cells/µl
Interval 473.0 to 767.0
|
|
Absolute CD8+T Cells
Month 54
|
975.0 cells/µl
Interval 672.0 to 1300.0
|
625.0 cells/µl
Interval 506.0 to 746.0
|
|
Absolute CD8+T Cells
Month 60
|
1002.0 cells/µl
Interval 657.0 to 1242.0
|
650.0 cells/µl
Interval 542.0 to 828.0
|
|
Absolute CD8+T Cells
Month 66
|
1072.0 cells/µl
Interval 807.0 to 1368.0
|
630.0 cells/µl
Interval 464.0 to 835.0
|
|
Absolute CD8+T Cells
Month 72
|
1062.5 cells/µl
Interval 720.0 to 1473.0
|
695.0 cells/µl
Interval 516.0 to 833.5
|
|
Absolute CD8+T Cells
Month 78
|
1196.5 cells/µl
Interval 1008.0 to 1615.0
|
592.0 cells/µl
Interval 412.0 to 869.0
|
|
Absolute CD8+T Cells
Month 84
|
1000.0 cells/µl
Interval 820.0 to 1189.0
|
692.0 cells/µl
Interval 511.0 to 825.0
|
SECONDARY outcome
Timeframe: Baseline and at months 1, 3, 6 and then every 6 months until month 84Population: Data of 42 patients (Efficacy set)
Median CD8+CD38+T cells/µl at baseline (IQR, interquartile range) and during follow-up
Outcome measures
| Measure |
CHI-patients
n=20 Participants
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=22 Participants
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Absolute CD8+CD38+T Cells
Month 48
|
147.0 cells/µl
Interval 62.0 to 274.5
|
78.0 cells/µl
Interval 40.0 to 132.0
|
|
Absolute CD8+CD38+T Cells
Month 54
|
80.0 cells/µl
Interval 50.0 to 208.0
|
81.0 cells/µl
Interval 25.0 to 140.0
|
|
Absolute CD8+CD38+T Cells
Baseline
|
104.0 cells/µl
Interval 66.0 to 160.0
|
871.5 cells/µl
Interval 506.0 to 1555.0
|
|
Absolute CD8+CD38+T Cells
Month 1
|
113.5 cells/µl
Interval 85.5 to 191.5
|
406.0 cells/µl
Interval 192.0 to 696.0
|
|
Absolute CD8+CD38+T Cells
Month 3
|
165.5 cells/µl
Interval 99.5 to 282.5
|
202.0 cells/µl
Interval 149.0 to 322.0
|
|
Absolute CD8+CD38+T Cells
Month 6
|
182.5 cells/µl
Interval 113.5 to 234.0
|
151.0 cells/µl
Interval 74.0 to 184.0
|
|
Absolute CD8+CD38+T Cells
Month 12
|
161.0 cells/µl
Interval 111.0 to 204.5
|
106.0 cells/µl
Interval 56.0 to 143.0
|
|
Absolute CD8+CD38+T Cells
19Month 18
|
203.5 cells/µl
Interval 77.0 to 280.0
|
97.0 cells/µl
Interval 67.0 to 175.0
|
|
Absolute CD8+CD38+T Cells
Month 24
|
129.0 cells/µl
Interval 74.0 to 241.0
|
71.0 cells/µl
Interval 28.0 to 171.0
|
|
Absolute CD8+CD38+T Cells
Month 30
|
128.0 cells/µl
Interval 72.0 to 199.0
|
86.0 cells/µl
Interval 69.0 to 135.0
|
|
Absolute CD8+CD38+T Cells
Month 36
|
163.0 cells/µl
Interval 63.0 to 191.0
|
79.0 cells/µl
Interval 12.0 to 121.0
|
|
Absolute CD8+CD38+T Cells
Month 42
|
144.5 cells/µl
Interval 47.0 to 210.0
|
102.0 cells/µl
Interval 42.0 to 121.0
|
|
Absolute CD8+CD38+T Cells
Month 60
|
110.0 cells/µl
Interval 40.0 to 180.0
|
69.0 cells/µl
Interval 39.0 to 109.0
|
|
Absolute CD8+CD38+T Cells
Month 66
|
100.0 cells/µl
Interval 33.0 to 195.0
|
69.0 cells/µl
Interval 31.0 to 136.0
|
|
Absolute CD8+CD38+T Cells
Month 72
|
110.0 cells/µl
Interval 46.0 to 217.0
|
53.0 cells/µl
Interval 33.0 to 120.4
|
|
Absolute CD8+CD38+T Cells
Month 78
|
134.0 cells/µl
Interval 80.0 to 330.0
|
60.0 cells/µl
Interval 23.0 to 125.0
|
|
Absolute CD8+CD38+T Cells
Month 84
|
120.0 cells/µl
Interval 48.0 to 170.0
|
64.0 cells/µl
Interval 37.0 to 156.0
|
Adverse Events
CHI-patients
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
PHI-patients
Serious events: 8 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CHI-patients
n=20 participants at risk
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=27 participants at risk
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Renal and urinary disorders
Renal pain
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Vascular disorders
Embolism arterial
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Vascular disorders
Cerebral infarction
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Vascular disorders
Basal ganglia stroke
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Anal prolapse
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Surgical and medical procedures
Renal stone removal
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Surgical and medical procedures
Hip arthroplasty
|
10.0%
2/20 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Surgical and medical procedures
Inguinal hernia repair
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Surgical and medical procedures
Leg amputation
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Surgical and medical procedures
Abortion induced
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
5.0%
1/20 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
3.7%
1/27 • Number of events 1 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
Other adverse events
| Measure |
CHI-patients
n=20 participants at risk
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
CHI-patients: Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
PHI-patients
n=27 participants at risk
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
PHI-patients: Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
55.0%
11/20 • Number of events 26 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
51.9%
14/27 • Number of events 30 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Abdominal tenderness
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Acute hepatitis C
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Anal chlamydia infection
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • Number of events 6 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
22.2%
6/27 • Number of events 6 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Bronchitis
|
20.0%
4/20 • Number of events 7 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
18.5%
5/27 • Number of events 6 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Injury, poisoning and procedural complications
Contusion
|
15.0%
3/20 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Psychiatric disorders
Depression
|
15.0%
3/20 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
22.2%
6/27 • Number of events 7 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
8/20 • Number of events 9 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
37.0%
10/27 • Number of events 20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Epididymitis
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 6 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
18.5%
5/27 • Number of events 6 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Gastrointestinal viral infectio
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Gingivitis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
14.8%
4/27 • Number of events 6 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Herpes zoster
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.0%
3/20 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
General disorders
Oedema peripheral
|
10.0%
2/20 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
14.8%
4/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Otitis media
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Nervous system disorders
Paraesthesia
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
14.8%
4/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Immune system disorders
Seasonal allergy
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Sinusitis
|
20.0%
4/20 • Number of events 5 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Psychiatric disorders
Sleep disorder
|
20.0%
4/20 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
11.1%
3/27 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
14.8%
4/27 • Number of events 5 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Syphilis
|
15.0%
3/20 • Number of events 9 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
29.6%
8/27 • Number of events 11 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Tonsillitis
|
10.0%
2/20 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Urethritis
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Urethritis gonococcal
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • Number of events 3 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
35.0%
7/20 • Number of events 8 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
14.8%
4/27 • Number of events 4 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
0.00%
0/27 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
|
Investigations
Weight decreased
|
0.00%
0/20 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
7.4%
2/27 • Number of events 2 • Adverse events per Patient were collected at the conducted half-yearly study visits, beginnig on individual study start up to the end of study (Month 84) or up to premature discontinuation. In case of premature discontinuation the adverse events occurring during post-follow-up observation period are also included in this report.
The safety dataset (safety population) is based on all patients enrolled in the study and having received at least one dose of study drugs, i.e. 42 eligible patients enrolled in the study (=efficacy dataset), and in addition 5 patients with primary HIV infection, who immediately started on study drugs (as defined by the study protocol) but turned out to be screening failures upon laboratory findings. The count of patients differed between both datasets (safety dataset N=47; CHI N=20, PHI N=27).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place