Conditions: HIV Infections
Keywords: Phase 2 Open-label Rollover Integrase Inhibitor Antiretroviral Agents Highly Active Antiretroviral Activity HAART HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus Acquired Immune Deficiency Syndrome Virus treatment experienced
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 192
Healthy volunteers: no

Brief summary:
The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.

Detailed description:

Arms:
arm 1: EVG 85 mg or 150 mg + RTV + ARV regimen

Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg.

Some participants may receive EVG 300 mg during the course of protocol amendment 2.

Interventions: intervention 1: EVG intervention 2: RTV intervention 3: ARV regimen
Intervention descriptions: intervention 1: Elvitegravir (EVG) tablet administered orally once daily with food intervention 2: Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food intervention 3: The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).

Protocol document: