Trial Outcomes & Findings for Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT) (NCT NCT00552240)
NCT ID: NCT00552240
Last Updated: 2014-01-27
Results Overview
VR is defined as HIV viral load of \<50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
154 participants
Primary outcome timeframe
baseline to week 48
Results posted on
2014-01-27
Participant Flow
Patients were recruited from 28 Sep 2007 through 23 Mar 2009 at 18 sites throughout the US. The sites were comprised of medical centers or private practice physicians.
There was a 28 day screening period where a genotype report was run. If patients were resistant to any of the study medication, they were not to be randomized into the study. Patients also needed to meet all inclusion/exclusion criteria in order to be eligible. 154 patients were enrolled but 2 were not treated, leaving 152 in full analysis set.
Participant milestones
| Measure |
Nevirapine (NVP) Plus Truvada
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
77
|
|
Overall Study
COMPLETED
|
51
|
59
|
|
Overall Study
NOT COMPLETED
|
24
|
18
|
Reasons for withdrawal
| Measure |
Nevirapine (NVP) Plus Truvada
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
9
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
6
|
0
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
Baseline characteristics by cohort
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Log10 HIV viral load
|
4.9 copies/mL
STANDARD_DEVIATION 0.8 • n=5 Participants
|
4.9 copies/mL
STANDARD_DEVIATION 0.7 • n=7 Participants
|
4.9 copies/mL
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
CD4+ count
|
178.9 cells/mm^3
STANDARD_DEVIATION 105.3 • n=5 Participants
|
183.5 cells/mm^3
STANDARD_DEVIATION 111.3 • n=7 Participants
|
181.2 cells/mm^3
STANDARD_DEVIATION 108.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to week 48Population: All treated patients. Early withdrawals were considered failures.
VR is defined as HIV viral load of \<50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With Virologic Response (VR)
Responders
|
46 participants
|
50 participants
|
|
Number of Participants With Virologic Response (VR)
Nonresponders
|
29 participants
|
27 participants
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients. Early withdrawals were considered failures.
HIV viral load \<50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
Responders
|
48 Participants
|
51 Participants
|
|
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
Nonresponders
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: baseline to week 48Population: Only includes treated patients with data in the Week 48 time window.
HIV viral load \<50 copies/ml measured at Week 48 among observed cases on-treatment.
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
Responders
|
42 Participants
|
48 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
Nonresponders
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients.
HIV viral load \<50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With Virologic Success (FDA Definition)
Responders
|
42 Participants
|
48 Participants
|
|
Number of Participants With Virologic Success (FDA Definition)
Nonresponders
|
33 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients
Time to response whereby patients withdrawing early were censored after their withdrawal
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
|
57 days
Interval 42.0 to 168.0
|
84 days
Interval 56.0 to 173.0
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All responders
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=55 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=65 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
|
55 days
Interval 41.0 to 85.0
|
84 days
Interval 56.0 to 169.0
|
SECONDARY outcome
Timeframe: baseline to week 24 and week 48Population: All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.
HIV viral load \> 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values \< 50 copies/ml)
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
At week 24
|
1 Participants
|
4 Participants
|
|
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
At week 48
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: baseline to week 2Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
HIV viral load < 50 copies/ml
|
6 Participants
|
5 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
HIV viral load ≥ 50 copies/ml
|
62 Participants
|
63 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Missing data
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: baseline to week 4Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
HIV viral load < 50 copies/ml
|
12 Participants
|
10 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
HIV viral load ≥ 50 copies/ml
|
53 Participants
|
62 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Missing data
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: baseline to week 6Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
HIV viral load ≥ 50 copies/ml
|
38 Participants
|
53 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Missing data
|
14 Participants
|
10 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
HIV viral load < 50 copies/ml
|
23 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: baseline to week 8Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
HIV viral load < 50 copies/ml
|
34 Participants
|
23 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
HIV viral load ≥ 50 copies/ml
|
25 Participants
|
50 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Missing data
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: baseline to week 12Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
HIV viral load < 50 copies/ml
|
42 Participants
|
43 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
HIV viral load ≥ 50 copies/ml
|
20 Participants
|
27 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Missing data
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: baseline to week 24Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
HIV viral load < 50 copies/ml
|
48 Participants
|
61 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
HIV viral load ≥ 50 copies/ml
|
9 Participants
|
5 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Missing data
|
18 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: baseline to week 36Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
HIV viral load < 50 copies/ml
|
53 Participants
|
55 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
HIV viral load ≥ 50 copies/ml
|
4 Participants
|
5 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Missing data
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
HIV viral load < 50 copies/ml
|
42 Participants
|
48 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
HIV viral load ≥ 50 copies/ml
|
2 Participants
|
8 Participants
|
|
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Missing data
|
31 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: baseline to week 2Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
HIV viral load < 400 copies/ml
|
24 Participants
|
17 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
HIV viral load ≥ 400 copies/ml
|
44 Participants
|
51 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Missing data
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: baseline to week 4Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
HIV viral load < 400 copies/ml
|
38 Participants
|
31 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
HIV viral load ≥ 400 copies/ml
|
27 Participants
|
41 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Missing data
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: baseline to week 6Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
HIV viral load < 400 copies/ml
|
40 Participants
|
44 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
HIV viral load ≥ 400 copies/ml
|
21 Participants
|
23 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Missing data
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: baseline to week 8Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
HIV viral load < 400 copies/ml
|
48 Participants
|
58 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
HIV viral load ≥ 400 copies/ml
|
11 Participants
|
15 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Missing data
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: baseline to week 12Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
HIV viral load < 400 copies/ml
|
56 Participants
|
63 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
HIV viral load ≥ 400 copies/ml
|
6 Participants
|
7 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Missing data
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: baseline to week 24Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
HIV viral load ≥ 400 copies/ml
|
6 Participants
|
3 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Missing data
|
18 Participants
|
11 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
HIV viral load < 400 copies/ml
|
51 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: baseline to week 36Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
HIV viral load < 400 copies/ml
|
54 Participants
|
59 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
HIV viral load ≥ 400 copies/ml
|
3 Participants
|
1 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Missing data
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients
Results within time windows, patients on-treatment
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
HIV viral load ≥ 400 copies/ml
|
1 Participants
|
2 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
HIV viral load < 400 copies/ml
|
43 Participants
|
54 Participants
|
|
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Missing data
|
31 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients
HIV viral load \>400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values \< 50 copies/ml)
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Number of Patients With Virologic Rebound to >400 Copies/ml
Rebound following response
|
2 Participants
|
6 Participants
|
|
Number of Patients With Virologic Rebound to >400 Copies/ml
No rebound following response
|
55 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients
AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting. Number of cases (no time-to analysis was performed due to small numbers).
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline to week 2Population: Includes only treated patients with data in the specified time window
Patients on-treatment, data within time windows
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=64 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=64 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 2.
|
62.6 cells/mm^3
Standard Deviation 80.9
|
61.0 cells/mm^3
Standard Deviation 69.7
|
SECONDARY outcome
Timeframe: baseline to week 4Population: Includes only treated patients with data in the specified time window
Patients on-treatment, data within time windows
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=65 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=70 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 4.
|
76.4 cells/mm^3
Standard Deviation 88.2
|
63.0 cells/mm^3
Standard Deviation 72.6
|
SECONDARY outcome
Timeframe: baseline to week 6Population: Includes only treated patients with data in the specified time window
Patients on-treatment, data within time windows
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=59 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=62 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 6.
|
87.2 cells/mm^3
Standard Deviation 86.0
|
78.4 cells/mm^3
Standard Deviation 67.6
|
SECONDARY outcome
Timeframe: baseline to week 8Population: Includes only treated patients with data in the specified time window
Patients on-treatment, data within time windows
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=58 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=69 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 8.
|
111.9 cells/mm^3
Standard Deviation 100.2
|
90.5 cells/mm^3
Standard Deviation 85.2
|
SECONDARY outcome
Timeframe: baseline to week 12Population: Includes only treated patients with data in the specified time window
Patients on-treatment, data within time windows
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=62 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=68 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 12.
|
123.1 cells/mm^3
Standard Deviation 109.5
|
102.2 cells/mm^3
Standard Deviation 103.9
|
SECONDARY outcome
Timeframe: baseline to week 24Population: Includes only treated patients with data in the specified time window
Patients on-treatment, data within time windows
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=59 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=68 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 24.
|
131.8 cells/mm^3
Standard Deviation 115.5
|
132.5 cells/mm^3
Standard Deviation 86.8
|
SECONDARY outcome
Timeframe: baseline to week 36Population: Includes only treated patients with data in the specified time window
Patients on-treatment, data within time windows
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=57 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=61 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 36.
|
147.6 cells/mm^3
Standard Deviation 120.7
|
120.5 cells/mm^3
Standard Deviation 99.4
|
SECONDARY outcome
Timeframe: baseline to week 48Population: Includes only treated patients with data in the specified time window
Patients on-treatment, data within time windows
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=46 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=54 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 48.
|
155.1 cells/mm^3
Standard Deviation 118.8
|
160.4 cells/mm^3
Standard Deviation 108.7
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients with data, Last observation carried forward (LOCF).
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=66 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=68 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in Fasting Plasma Total Cholesterol Level
|
18.2 mg/dl
Standard Deviation 26.5
|
13.8 mg/dl
Standard Deviation 39.5
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients with data, Last observation carried forward (LOCF)
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=66 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=68 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in Fasting Plasma Triglycerides Level
|
-4.7 mg/dl
Standard Deviation 87.6
|
8.4 mg/dl
Standard Deviation 120.4
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients with data, Last observation carried forward (LOCF)
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=66 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=68 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
|
9.6 mg/dl
Standard Deviation 11.8
|
3.5 mg/dl
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients with data, Last observation carried forward (LOCF)
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=66 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=68 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
|
8.7 mg/dl
Standard Deviation 21.5
|
6.9 mg/dl
Standard Deviation 32.2
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients with data, Last observation carried forward (LOCF)
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=66 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=68 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
|
-0.38 ratio
Standard Deviation 0.96
|
-0.02 ratio
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients with data, Last observation carried forward (LOCF)
Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction \[MI\] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=67 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=71 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in Framingham Score
|
-0.09 percent 10-year risk
Standard Deviation 2.01
|
0.14 percent 10-year risk
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: baseline to week 48Population: Not calculated as no data on family history of cardiovascular disease were available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to week 48Population: Includes only treated patients with data for the specified time window
using 4-variable Modification of Diet in Renal Disease (MDRD) formula
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=66 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=68 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
|
-0.06 ml/min/1.73m^2
Standard Deviation 33.90
|
-12.81 ml/min/1.73m^2
Standard Deviation 35.61
|
SECONDARY outcome
Timeframe: baseline to week 48Population: All treated patients with data
Number of pills not returned / number of treatment days in percent (%)
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=71 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=76 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Percentage Adherence by Pill Count
|
94.3 percentage adherence
Standard Deviation 17.7
|
97.0 percentage adherence
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: baseline to week 48Population: Includes only treated patients with data in the specified time window
Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to week 52Population: Full Analysis set
Cumulative incidence of patients with AIDS progression are shown
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Incidence of Patients With AIDS Progression at Each Visit
week 36
|
0 participants
|
3 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 0
|
0 participants
|
0 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 2
|
0 participants
|
0 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 4
|
0 participants
|
0 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 6
|
0 participants
|
1 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 8
|
0 participants
|
1 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 12
|
0 participants
|
2 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 24
|
0 participants
|
3 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 48
|
1 participants
|
3 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
week 50
|
1 participants
|
3 participants
|
|
Incidence of Patients With AIDS Progression at Each Visit
End of Study Visit
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: baseline to week 52Population: All treated patients
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Proportion of Patients Reporting CNS Side Effects of Any Severity
|
25 participants
|
23 participants
|
SECONDARY outcome
Timeframe: baseline to week 52Population: All treated patients
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Proportion of Patients Reporting Hepatic Events of Any Severity
|
5 participants
|
24 participants
|
SECONDARY outcome
Timeframe: baseline to week 52Population: All treated patients
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Proportion of Patients Reporting Rash of Any Severity
|
21 participants
|
19 participants
|
SECONDARY outcome
Timeframe: baseline to week 52Population: All treated patients
Outcome measures
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 Participants
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 Participants
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Grade 2 moderate
|
25 participants
|
31 participants
|
|
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Grade 3 severe
|
8 participants
|
7 participants
|
|
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Grade 4 potential lifethreatening
|
7 participants
|
3 participants
|
Adverse Events
Nevirapine (NVP) Plus Truvada
Serious events: 10 serious events
Other events: 50 other events
Deaths: 0 deaths
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Serious events: 7 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 participants at risk
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 participants at risk
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Infections and infestations
Cerebral toxoplasmosis
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Immune system disorders
Immune reconstitution syndrome
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
1.3%
1/75 • 52 weeks
|
2.6%
2/77 • 52 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/75 • 52 weeks
|
2.6%
2/77 • 52 weeks
|
|
Psychiatric disorders
Completed suicide
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Nervous system disorders
Mononeuropathy multiplex
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
1/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Hepatobiliary disorders
Hepatitis
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Investigations
Transaminases increased
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.3%
1/75 • 52 weeks
|
0.00%
0/77 • 52 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
Other adverse events
| Measure |
Nevirapine (NVP) Plus Truvada
n=75 participants at risk
Nevirapine 200 mg bis in die (BID)
|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
n=77 participants at risk
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
8/75 • 52 weeks
|
23.4%
18/77 • 52 weeks
|
|
Infections and infestations
Sinusitis
|
4.0%
3/75 • 52 weeks
|
9.1%
7/77 • 52 weeks
|
|
Infections and infestations
Anogenital warts
|
1.3%
1/75 • 52 weeks
|
7.8%
6/77 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
2.7%
2/75 • 52 weeks
|
6.5%
5/77 • 52 weeks
|
|
Psychiatric disorders
Insomnia
|
5.3%
4/75 • 52 weeks
|
9.1%
7/77 • 52 weeks
|
|
Nervous system disorders
Headache
|
14.7%
11/75 • 52 weeks
|
14.3%
11/77 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
5.3%
4/75 • 52 weeks
|
6.5%
5/77 • 52 weeks
|
|
Eye disorders
Ocular icterus
|
1.3%
1/75 • 52 weeks
|
14.3%
11/77 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
7/75 • 52 weeks
|
10.4%
8/77 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
5/75 • 52 weeks
|
1.3%
1/77 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
12/75 • 52 weeks
|
19.5%
15/77 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
13.3%
10/75 • 52 weeks
|
14.3%
11/77 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
3/75 • 52 weeks
|
7.8%
6/77 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/75 • 52 weeks
|
5.2%
4/77 • 52 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/75 • 52 weeks
|
15.6%
12/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.3%
7/75 • 52 weeks
|
3.9%
3/77 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.3%
1/75 • 52 weeks
|
7.8%
6/77 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
6/75 • 52 weeks
|
3.9%
3/77 • 52 weeks
|
|
General disorders
Fatigue
|
17.3%
13/75 • 52 weeks
|
13.0%
10/77 • 52 weeks
|
|
General disorders
Oedema peripheral
|
2.7%
2/75 • 52 weeks
|
5.2%
4/77 • 52 weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER