Human Immunodeficiency Virus (HIV) Infections
Conditions
Keywords
HIV-Infected Patients Evidencing Virologic Suppression
Brief summary
The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.
Interventions
Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks). * Absence of evidence or suspected virologic failure on antiretroviral therapy * Absence of known primary mutations in the protease gene * Only 1 highly active antiretroviral therapy (HAART) prior to current one * HIV RNA \< 50 copies/mL in the last 6 months (single blip below 200 c/mL allowed) * On ATV/RTV +2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 NRTI + tenofovir \[TDF\]) for at least 8 weeks before study entry, without treatment-limiting adverse effects
Exclusion criteria
* Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. * Active disease condition (e.g. moderate to severe hepatic impairment/active renal disease/history of clinically significant heart conduction disease) * Patients with chronic hepatitis B receiving lamivudine (3TC), Tenofovir Disoproxil Fumarate (TDF) or emtricitabine (FTC). * CD4 \< 100 cells/mm3 * Grade IV laboratory values: Hemoglobin \< 6.5 g/dL or white blood cells (WBC) \<800/mmm3 or absolute neutrophil count \< 500/mm3, or platelets \< 20,000/mm3 or diffuse petechiae.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Failure Through Week 48 | Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virological Rebound Through Week 48 | Week 48 | 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. |
| Percentage of Participants With Virological Rebound Through Week 96 | Week 96 | 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. |
| Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Through Week 100 | 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). |
| Proportion of Participants With Virologic Rebound Through Week 96 | Through Week 96 | 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. |
| Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 | Baseline, Week 24 | — |
| Mean Change From Baseline in CD4 Cell Count at Week 48 | Baseline, Week 48 | — |
| Percentage of Participants With Treatment Failure Through Week 96 | Week 96 | 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. |
| Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | From Baseline through Week 96 | 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). |
| 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 | Baseline, Week 48 | Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics. |
| 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 | Baseline, Week 96 | Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics. |
| Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48 | 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. |
| Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96 | 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. |
| Mean Change From Baseline in CD4 Cell Count at Week 96 | Baseline, Week 96 | — |
Countries
Spain
Participant flow
Pre-assignment details
63 participants were enrolled in this study; 2 were never treated (1 no longer met study criteria and 1 concomitant medication not permitted).
Participants by arm
| Arm | Count |
|---|---|
| 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) | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Subject No Longer Met Study Criteria | 2 |
| Overall Study | Subject Withdrew Consent | 2 |
Baseline characteristics
| Characteristic | Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. |
|---|---|
| Age Continuous | 43 years STANDARD_DEVIATION 9.5 |
| CD4 Count | 559 cell/mm3 STANDARD_DEVIATION 272.8 |
| Cluster of Differentiation 4 (CD4) Categories CD4 Count <200 cells/mm3 | 3 participants |
| Cluster of Differentiation 4 (CD4) Categories CD4 Count >=200 cells/mm3 | 58 participants |
| Fasting High-Density Lipoprotein (HDL) Cholesterol | 45 mg/dL STANDARD_DEVIATION 10.4 |
| Fasting Low-Density Lipoprotein (LDL) Cholesterol | 112 mg/dL STANDARD_DEVIATION 52.3 |
| Fasting Non-HDL Cholesterol | 144 mg/dL STANDARD_DEVIATION 57.9 |
| Fasting Total Cholesterol | 189 mg/dL STANDARD_DEVIATION 57 |
| Fasting Triglycerides | 164 mg/dL STANDARD_DEVIATION 95.7 |
| HIV RNA | 1.71 log10 c/mL STANDARD_DEVIATION 0.152 |
| Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories HIV RNA <50 c/mL | 60 Participants |
| Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories HIV RNA >=50 c/mL | 1 Participants |
| Race/Ethnicity, Customized White | 61 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 61 |
| serious Total, serious adverse events | 12 / 61 |
Outcome results
Primary
Percentage of Participants With Treatment Failure Through Week 48
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.
Time frame: Week 48
Population: Treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Percentage of Participants With Treatment Failure Through Week 48 | 21.3 Percentage of Participants |
95% CI: [11.9, 33.7]exact binomial methods
Secondary
Cumulative Proportion of Participants Without Treatment Failure Through Week 100
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).
Time frame: Through Week 100
Population: treated participants; n= the number at risk entering interval
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 4 - 8 (n=61) | 0.9836 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 8 - 12 (n=60) | 0.9508 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 12 - 16 (n=58) | 0.9016 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 16 - 20 (n=55) | 0.8852 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 20 - 24 (n=54) | 0.8689 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 24 - 28 (n=53) | 0.8525 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 32 - 36 (n=52) | 0.8197 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 36 - 40 (n=50) | 0.7869 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 48 - 52 (n=48) | 0.7541 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 56 - 60 (n=46) | 0.7377 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 64 - 68 (n=45) | 0.7049 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 68 - 72 (n=43) | 0.6885 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 72 - 76 (n=42) | 0.6721 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 84 - 88 (n=41) | 0.6557 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 92 - 96 (n=40) | 0.6557 proportion of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Cumulative Proportion of Participants Without Treatment Failure Through Week 100 | Interval Week 96 - 100 (n=31) | 0.6557 proportion of participants |
Secondary
Mean Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline, Week 48
Population: n=number of participants with CD4 cell count at baseline and at Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Mean Change From Baseline in CD4 Cell Count at Week 48 | Baseline Value (n=61) | 559 cells /mm3 | Standard Deviation 272.8 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Mean Change From Baseline in CD4 Cell Count at Week 48 | Change at Week 48 (n=46) | 53 cells /mm3 | Standard Deviation 203.5 |
95% CI: [-7.1, 113.7]normal approximation for 95% CI
Secondary
Mean Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline, Week 96
Population: n=number of participants with CD4 cell count at baseline and at Week 96.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Mean Change From Baseline in CD4 Cell Count at Week 96 | Change at Week 96 (n=40) | 63 cells /mm3 | Standard Deviation 208.1 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Mean Change From Baseline in CD4 Cell Count at Week 96 | Baseline Value (n=61) | 559 cells /mm3 | Standard Deviation 272.8 |
95% CI: [-4, 129.1]normal approximation for 95% CI
Secondary
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24
Time frame: Baseline, Week 24
Population: n=number of participants with CD4 cell count at baseline and at Week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
95% CI: [12.3, 109.8]normal approximation for 95% CI
Secondary
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
Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Time frame: Baseline, Week 48
Population: n= number of treated participants with baseline measure and measure at Week 48
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
Comparison: Percent Change from Baseline in Fasting Total Cholesterol at Week 4895% CI: [2.5, 14.6]normal approximation for 95% CI
Comparison: Percent Change from Baseline in Fasting HDL Cholesterol at Week 4895% CI: [-3.9, 8.8]normal approximation for 95% CI
Comparison: Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 4895% CI: [4, 20.8]normal approximation for 95% CI
Comparison: Percent Change from Baseline in Fasting LDL Cholesterol at Week 4895% CI: [8, 31.7]normal approximation for 95% CI
Comparison: Percent Change from Baseline in Fasting Triglycerides at Week 4895% CI: [-0.4, 34.4]normal approximation for 95% CI
Secondary
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
Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Time frame: Baseline, Week 96
Population: n=number of treated participants with baseline measure and measure at Week 96
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
Comparison: Percent Change from Baseline in Fasting Total Cholesterol at Week 9695% CI: [6.9, 20.1]normal approximation for 95% CI
Comparison: Percent Change from Baseline in Fasting HDL Cholesterol at Week 9695% CI: [-6, 10.2]normal approximation for 95% CI
Comparison: Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 9695% CI: [10.3, 28.4]normal approximation for 95% CI
Comparison: Percent Change from Baseline in Fasting LDL Cholesterol at Week 9695% CI: [15.3, 42]normal approximation for 95% CI
Comparison: Percent Change from Baseline in Fasting Triglycerides at Week 9695% CI: [-9.5, 41.6]normal approximation for 95% CI
Secondary
Number of Participants With Genotype Substitutions for 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.
Time frame: Week 48
Population: Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48 | RT substitutions | 0 participants |
Secondary
Number of Participants With Genotype Substitutions for 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.
Time frame: Week 96
Population: Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96 | RT substitutions | 0 participants |
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
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).
Time frame: From Baseline through Week 96
Population: Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Deaths | 3.3 percentage of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | SAEs | 19.7 percentage of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
Secondary
Percentage of Participants With Treatment Failure Through Week 96
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.
Time frame: Week 96
Population: Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \> 50 c/mL.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Percentage of Participants With Treatment Failure Through Week 96 | HIV RNA >= 400 c/mL(n=61) | 34.4 percentage of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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 |
95% CI: [22.7, 47.7]exact binomial methods
Secondary
Percentage of Participants With Virological Rebound Through Week 48
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.
Time frame: Week 48
Population: Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \> 50 c/mL.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Percentage of Participants With Virological Rebound Through Week 48 | HIV RNA >= 400 c/mL (n=61) | 12 percentage of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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
Percentage of Participants With Virological Rebound Through Week 96
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.
Time frame: Week 96
Population: Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \> 50 c/mL.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | Percentage of Participants With Virological Rebound Through Week 96 | HIV RNA >= 400 c/mL (n=61) | 14.8 percentage of participants |
| Atazanavir (ATV)/Ritonavir (RTV) Monotherapy | 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
Proportion of Participants With Virologic Rebound Through Week 96
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.
Time frame: Through Week 96
Population: 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.