HIV, Combination Therapy
Conditions
Brief summary
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
Detailed description
Allocation: Randomized nonstratified Intervention model: Parallel versus comparator
Interventions
DRUGAtazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
DRUGRitonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
DRUGRaltegravir
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus any third agent for at least 3 months immediately prior to screening * Virologic suppression (HIV-1 RNA \<50 c/mL) for at least 3 months immediately prior to screening * Virologic suppression (HIV-1 RNA \<40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period * Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent Key
Exclusion criteria
* History of switch in highly active antiretroviral therapy due to virologic failure * History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine) * History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study * Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir * Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 | From Day 1 to Week 24 | HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Virologic Rebound at Weeks 24 and 48 | Day 1 to Weeks 28 and 48 | Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. |
| Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Day 1 to Week 24 | Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients |
| Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 | From Day 1 to Week 48 | Percentages of patients with HIV-1 RNA levels \<40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals. |
| Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Day 1 to Week 48 | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. |
| Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | From Baseline to Week 48 | LD=low-density lipoprotein; HDL=high-density lipoprotein. |
| Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Day 1 to Week 48 | Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients |
Countries
France, Germany, Italy, Poland, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Of 132 patients enrolled, 109 were randomized to receive treatment, and 23 patients were not randomized for the following reasons: 10 did not meet study criteria; 5 withdrew consent; 3 were lost to follow-up, and 5 withdrew for other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Atazanavir/Ritonavir + Raltegravir Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks. | 72 |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks. | 37 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lack of Efficacy | 3 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Patient began prohibited medication | 0 | 1 |
| Overall Study | Patient moved from area | 1 | 0 |
| Overall Study | Poor compliance/noncompliance | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | Atazanavir/Ritonavir + Raltegravir | Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Total |
|---|---|---|---|
| Age, Continuous | 44.0 Years | 44.0 Years | 44.0 Years |
| Age, Customized 65-85 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Customized < 65 years | 69 Participants | 36 Participants | 105 Participants |
| Cardiovascular disease risk factors Current smoker | 27 Participants | 11 Participants | 38 Participants |
| Cardiovascular disease risk factors Diabetes mellitus | 3 Participants | 1 Participants | 4 Participants |
| Cardiovascular disease risk factors Family history of premature coronary heart disease | 4 Participants | 0 Participants | 4 Participants |
| Cardiovascular disease risk factors Hypertension | 5 Participants | 6 Participants | 11 Participants |
| Cardiovascular disease risk factors Previous smoker | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 13 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 38 Participants | 23 Participants | 61 Participants |
| Mean CD4 count | 587.7 Cells/mm^3 STANDARD_DEVIATION 252.09 | 630.9 Cells/mm^3 STANDARD_DEVIATION 270.02 | 601.5 Cells/mm^3 STANDARD_DEVIATION 257.48 |
| Median CD4 count | 588.5 Cells/mm^3 | 639.5 Cells/mm^3 | 593.0 Cells/mm^3 |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 54 Participants | 24 Participants | 78 Participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 58 Participants | 31 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 72 | 23 / 37 |
| serious Total, serious adverse events | 4 / 72 | 1 / 37 |
Outcome results
Primary
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.
Time frame: From Day 1 to Week 24
Population: All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 | 80.6 Percentage of participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 | 94.6 Percentage of participants |
Secondary
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
LD=low-density lipoprotein; HDL=high-density lipoprotein.
Time frame: From Baseline to Week 48
Population: All participants who received study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting total cholesterol | 11.7 mg/dL | Standard Error 5.239 |
| Atazanavir/Ritonavir + Raltegravir | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting non-HDL cholesterol | 9.0 mg/dL | Standard Error 4.983 |
| Atazanavir/Ritonavir + Raltegravir | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting HDL cholesterol | 2.7 mg/dL | Standard Error 2.055 |
| Atazanavir/Ritonavir + Raltegravir | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting triglycerides | 14.7 mg/dL | Standard Error 16.667 |
| Atazanavir/Ritonavir + Raltegravir | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting LDL cholesterol | 7.7 mg/dL | Standard Error 3.986 |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting triglycerides | -17.6 mg/dL | Standard Error 16.994 |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting total cholesterol | -10.2 mg/dL | Standard Error 4.769 |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting LDL cholesterol | -5.4 mg/dL | Standard Error 4.691 |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting HDL cholesterol | -0.3 mg/dL | Standard Error 1.915 |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | Fasting non-HDL cholesterol | -9.8 mg/dL | Standard Error 4.43 |
Secondary
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Time frame: Day 1 to Week 24
Population: Patients who received study drug, who had an HIV-1 RNA measurement at the analysis week and who experienced virologic rebound.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Genotypable (GI)/phenotypable isolates (PI) | 4 Participants |
| Atazanavir/Ritonavir + Raltegravir | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Emergent genotypic substitutions in GI pts (n=4,0) | 4 Participants |
| Atazanavir/Ritonavir + Raltegravir | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Phenotypic resistance in PI pts (n=4,0) | 1 Participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Genotypable (GI)/phenotypable isolates (PI) | 0 Participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Emergent genotypic substitutions in GI pts (n=4,0) | 0 Participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Phenotypic resistance in PI pts (n=4,0) | 0 Participants |
Secondary
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Time frame: Day 1 to Week 48
Population: Participants with virologic rebound
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Genotypable (GI)/phenotypable isolates (PI) | 5 Participants |
| Atazanavir/Ritonavir + Raltegravir | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Emergent genotypic substitutions in GI pts (n=5,0) | 5 Participants |
| Atazanavir/Ritonavir + Raltegravir | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Phenotypic resistance in PI pts (n=5,0) | 1 Participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Genotypable (GI)/phenotypable isolates (PI) | 0 Participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Emergent genotypic substitutions in GI pts (n=5,0) | 0 Participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Phenotypic resistance in PI pts (n=5,0) | 0 Participants |
Secondary
Number of Participants With Virologic Rebound at Weeks 24 and 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
Time frame: Day 1 to Weeks 28 and 48
Population: All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Number of Participants With Virologic Rebound at Weeks 24 and 48 | Week 24: Virologic rebound | 7 Participants |
| Atazanavir/Ritonavir + Raltegravir | Number of Participants With Virologic Rebound at Weeks 24 and 48 | Week 48: Virologic rebound | 9 Participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Participants With Virologic Rebound at Weeks 24 and 48 | Week 24: Virologic rebound | 1 Participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Participants With Virologic Rebound at Weeks 24 and 48 | Week 48: Virologic rebound | 1 Participants |
Secondary
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Time frame: Day 1 to Week 48
Population: All participants who received study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | SAEs | 4 Particpants |
| Atazanavir/Ritonavir + Raltegravir | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Treatment-emergent AEs leading to discontinuation | 3 Particpants |
| Atazanavir/Ritonavir + Raltegravir | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Related SAEs | 1 Particpants |
| Atazanavir/Ritonavir + Raltegravir | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Treatment-emergent AEs | 51 Particpants |
| Atazanavir/Ritonavir + Raltegravir | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Deaths | 0 Particpants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Treatment-emergent AEs | 28 Particpants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Deaths | 0 Particpants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | SAEs | 1 Particpants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Related SAEs | 0 Particpants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | Treatment-emergent AEs leading to discontinuation | 1 Particpants |
Secondary
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Percentages of patients with HIV-1 RNA levels \<40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.
Time frame: From Day 1 to Week 48
Population: All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 | 69.4 Percentage of participants |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 | 86.5 Percentage of participants |