Phase 4
Completed N=109
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
HIV, Combination Therapy
Source: ClinicalTrials.gov NCT01332227 ↗
Enrolled (actual)
109
Serious AEs
4.6%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 — 80.6; 94.6 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 |
80.6; 94.6 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 |
69.4; 86.5 | — |
| SECONDARY Number of Participants With Virologic Rebound at Weeks 24 and 48 |
7; 1; 9; 1 | — |
| 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 |
4; 0; 4; 0; 1; 0 | — |
| 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 |
5; 0; 5; 0; 1; 0 | — |
| 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 |
0; 0; 4; 1; 1; 0 | — |
| SECONDARY Mean Changes in Fasting Lipid Levels From Baseline to Week 48 |
11.7; -10.2; 7.7; -5.4; 2.7; -0.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01332227). 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. Informational only — not medical advice.