Phase 3
N=61
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
Human Immunodeficiency Virus (HIV) Infections
Bottom Line
View on ClinicalTrials.gov: NCT00337467 ↗Enrolled (actual)
61
Serious AEs
19.7%
Results posted
Jul 2010
Primary outcome: Primary: Percentage of Participants With Treatment Failure Through Week 48 — 21.3 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atazanavir + Ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Failure Through Week 48 |
21.3 | — |
| SECONDARY Percentage of Participants With Treatment Failure Through Week 96 |
34.4; 43.3 | — |
| SECONDARY Percentage of Participants With Virological Rebound Through Week 48 |
12; 26.7 | — |
| SECONDARY Percentage of Participants With Virological Rebound Through Week 96 |
14.8; 33.3 | — |
| SECONDARY Cumulative Proportion of Participants Without Treatment Failure Through Week 100 |
0.9836; 0.9508; 0.9016; 0.8852; 0.8689; 0.8525 | — |
| SECONDARY Proportion of Participants With Virologic Rebound Through Week 96 |
— | — |
| SECONDARY Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 |
559; 61 | — |
| SECONDARY Mean Change From Baseline in CD4 Cell Count at Week 48 |
559; 53 | — |
| SECONDARY Mean Change From Baseline in CD4 Cell Count at Week 96 |
559; 63 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs |
75.4; 13.1; 18; 3.3; 3.3; 19.7 | — |
| 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 |
9; 2; 12; 20; 17 | — |
| 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 |
14; 2; 19; 29; 16 | — |
| SECONDARY Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48 |
1; 0 | — |
| SECONDARY Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96 |
2; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00337467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.