Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Anti-Retroviral Agents; Elvitegravir; Ritonavir

Criteria

Inclusion Criteria:

• Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity.

• Males and females of childbearing potential must agree to utilize effective contraception methods.

• Ability to understand and sign a written informed consent form.

Exclusion Criteria:

• Females who are pregnant or breastfeeding.

• Participation in any other clinical trial without prior approval from the Sponsor.

• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.

• Subjects receiving ongoing therapy with contraindicated drugs.