Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Emtricitabine; Raltegravir Potassium; Reverse Transcriptase Inhibitors; Ritonavir; Tenofovir

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