Trial Outcomes & Findings for Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression (NCT NCT00337467)
NCT ID: NCT00337467
Last Updated: 2010-07-19
Results Overview
Treatment Failure through Week 48 defined as virologic rebound (HIV RNA \>=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) \>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \>=400 c/mL followed by discontinuation of study therapy.
COMPLETED
PHASE3
61 participants
Week 48
2010-07-19
Participant Flow
63 participants were enrolled in this study; 2 were never treated (1 no longer met study criteria and 1 concomitant medication not permitted).
Participant milestones
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
Discontinued Prior to Week 96
|
10
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Subject Withdrew Consent
|
2
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Subject No Longer Met Study Criteria
|
2
|
Baseline Characteristics
Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression
Baseline characteristics by cohort
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Age Continuous
|
43 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
61 participants
n=5 Participants
|
|
Cluster of Differentiation 4 (CD4) Categories
CD4 Count <200 cells/mm3
|
3 participants
n=5 Participants
|
|
Cluster of Differentiation 4 (CD4) Categories
CD4 Count >=200 cells/mm3
|
58 participants
n=5 Participants
|
|
Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories
HIV RNA <50 c/mL
|
60 Participants
n=5 Participants
|
|
Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories
HIV RNA >=50 c/mL
|
1 Participants
n=5 Participants
|
|
CD4 Count
|
559 cell/mm3
STANDARD_DEVIATION 272.8 • n=5 Participants
|
|
Fasting High-Density Lipoprotein (HDL) Cholesterol
|
45 mg/dL
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Fasting Low-Density Lipoprotein (LDL) Cholesterol
|
112 mg/dL
STANDARD_DEVIATION 52.3 • n=5 Participants
|
|
Fasting Non-HDL Cholesterol
|
144 mg/dL
STANDARD_DEVIATION 57.9 • n=5 Participants
|
|
Fasting Total Cholesterol
|
189 mg/dL
STANDARD_DEVIATION 57 • n=5 Participants
|
|
Fasting Triglycerides
|
164 mg/dL
STANDARD_DEVIATION 95.7 • n=5 Participants
|
|
HIV RNA
|
1.71 log10 c/mL
STANDARD_DEVIATION 0.152 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Treated participants
Treatment Failure through Week 48 defined as virologic rebound (HIV RNA \>=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) \>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \>=400 c/mL followed by discontinuation of study therapy.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Percentage of Participants With Treatment Failure Through Week 48
|
21.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 96Population: Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \> 50 c/mL.
Treatment Failure through Week 96 defined as virologic rebound (HIV RNA \>=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA \>= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA \< 50 c/mL.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Percentage of Participants With Treatment Failure Through Week 96
HIV RNA >= 400 c/mL(n=61)
|
34.4 percentage of participants
|
|
Percentage of Participants With Treatment Failure Through Week 96
HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)
|
43.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \> 50 c/mL.
Virological rebound is defined as confirmed on-treatment HIV RNA \>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \>=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA \>=50 c/m, latter analysis performed on subjects with baseline HIV RNA \< 50 c/mL.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Percentage of Participants With Virological Rebound Through Week 48
HIV RNA >= 400 c/mL (n=61)
|
12 percentage of participants
|
|
Percentage of Participants With Virological Rebound Through Week 48
HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)
|
26.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \> 50 c/mL.
Virological rebound is defined as confirmed on-treatment HIV RNA \>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \>=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA \>=50 c/m, latter analysis performed on subjects with baseline HIV RNA \< 50 c/mL.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Percentage of Participants With Virological Rebound Through Week 96
HIV RNA >= 400 c/mL (n=61)
|
14.8 percentage of participants
|
|
Percentage of Participants With Virological Rebound Through Week 96
HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Through Week 100Population: treated participants; n= the number at risk entering interval
This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
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Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 4 - 8 (n=61)
|
0.9836 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 8 - 12 (n=60)
|
0.9508 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 12 - 16 (n=58)
|
0.9016 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 16 - 20 (n=55)
|
0.8852 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 20 - 24 (n=54)
|
0.8689 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 24 - 28 (n=53)
|
0.8525 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 32 - 36 (n=52)
|
0.8197 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 36 - 40 (n=50)
|
0.7869 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 48 - 52 (n=48)
|
0.7541 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 56 - 60 (n=46)
|
0.7377 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 64 - 68 (n=45)
|
0.7049 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 68 - 72 (n=43)
|
0.6885 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 72 - 76 (n=42)
|
0.6721 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 84 - 88 (n=41)
|
0.6557 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 92 - 96 (n=40)
|
0.6557 proportion of participants
|
|
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Interval Week 96 - 100 (n=31)
|
0.6557 proportion of participants
|
SECONDARY outcome
Timeframe: Through Week 96Population: This analysis was not done; however, percentage of participants with virologic rebound through Weeks 48 and 96 are reported in Secondary Outcome Measures 3 and 4. Time to reatment failure (defined as the earlier of virologic rebound or treatment discontinuation) is reported in Secondary Outcome Measure 5.
Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: n=number of participants with CD4 cell count at baseline and at Week 24
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24
Baseline Value (n=61)
|
559 cells /mm3
Standard Deviation 272.8
|
|
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24
Change at Week 24 (n=51)
|
61 cells /mm3
Standard Deviation 173.3
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: n=number of participants with CD4 cell count at baseline and at Week 48.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Mean Change From Baseline in CD4 Cell Count at Week 48
Baseline Value (n=61)
|
559 cells /mm3
Standard Deviation 272.8
|
|
Mean Change From Baseline in CD4 Cell Count at Week 48
Change at Week 48 (n=46)
|
53 cells /mm3
Standard Deviation 203.5
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: n=number of participants with CD4 cell count at baseline and at Week 96.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Mean Change From Baseline in CD4 Cell Count at Week 96
Baseline Value (n=61)
|
559 cells /mm3
Standard Deviation 272.8
|
|
Mean Change From Baseline in CD4 Cell Count at Week 96
Change at Week 96 (n=40)
|
63 cells /mm3
Standard Deviation 208.1
|
SECONDARY outcome
Timeframe: From Baseline through Week 96Population: Treated Participants
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Grade 3 to Grade 4 AEs Related to Study Therapy
|
3.3 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Deaths
|
3.3 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
SAEs
|
19.7 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
SAEs Related to Study Therapy
|
0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
AEs Leading to Discontinuation
|
4.9 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Lipodystrophy-Related AEs
|
1.6 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
All Grades AEs Related to Study Therapy
|
13.1 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
All Grades AEs
|
75.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Grade 3 to Grade 4 AEs
|
18 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: n= number of treated participants with baseline measure and measure at Week 48
Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Total Cholesterol (n=36)
|
9 percent change
Standard Deviation 18.0
|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
HDL Cholesterol (n=35)
|
2 percent change
Standard Deviation 18.5
|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Non-HDL Cholesterol (n=35)
|
12 percent change
Standard Deviation 24.4
|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
LDL Cholesterol (n=33)
|
20 percent change
Standard Deviation 33.4
|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Triglycerides (n=36)
|
17 percent change
Standard Deviation 51.4
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: n=number of treated participants with baseline measure and measure at Week 96
Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=61 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Total Cholesterol (n=29)
|
14 percent change
Standard Deviation 17.4
|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
HDL Cholesterol (n=29)
|
2 percent change
Standard Deviation 21.2
|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Non-HDL Cholesterol (n=29)
|
19 percent change
Standard Deviation 23.7
|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
LDL Cholesterol (n=28)
|
29 percent change
Standard Deviation 34.4
|
|
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Triglycerides (n=29)
|
16 percent change
Standard Deviation 67.2
|
SECONDARY outcome
Timeframe: Week 48Population: Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.
International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=7 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48
IAS-USA-defined major PI substitutions
|
1 participants
|
|
Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48
RT substitutions
|
0 participants
|
SECONDARY outcome
Timeframe: Week 96Population: Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.
International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.
Outcome measures
| Measure |
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
n=9 Participants
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96
IAS-USA-defined major PI substitutions
|
2 participants
|
|
Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96
RT substitutions
|
0 participants
|
Adverse Events
ATV/RTV Monotherapy
Serious adverse events
| Measure |
ATV/RTV Monotherapy
n=61 participants at risk
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Psychiatric disorders
SUICIDAL IDEATION
|
1.6%
1/61
|
|
Psychiatric disorders
DYSTHYMIC DISORDER
|
1.6%
1/61
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
1.6%
1/61
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
1.6%
1/61
|
|
Nervous system disorders
HEADACHE
|
1.6%
1/61
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
1.6%
1/61
|
|
Infections and infestations
SEPSIS
|
1.6%
1/61
|
|
Infections and infestations
PNEUMONIA
|
3.3%
2/61
|
|
Infections and infestations
APPENDICITIS
|
1.6%
1/61
|
|
Infections and infestations
EYE INFECTION SYPHILITIC
|
1.6%
1/61
|
|
Reproductive system and breast disorders
TESTICULAR ATROPHY
|
1.6%
1/61
|
|
Injury, poisoning and procedural complications
ACCIDENT
|
1.6%
1/61
|
|
General disorders
MULTI-ORGAN FAILURE
|
1.6%
1/61
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
1.6%
1/61
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
1.6%
1/61
|
Other adverse events
| Measure |
ATV/RTV Monotherapy
n=61 participants at risk
ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
|
|---|---|
|
Psychiatric disorders
DEPRESSION
|
6.6%
4/61
|
|
Nervous system disorders
HEADACHE
|
8.2%
5/61
|
|
Infections and infestations
TOOTH INFECTION
|
6.6%
4/61
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
8.2%
5/61
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
11.5%
7/61
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
9.8%
6/61
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER