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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: RTV; Drug: ARV regimen; Drug: EVG

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445146

GS-US-183-0130

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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192 participants in 1 patient group

EVG+RTV

Experimental group

Description:

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.

Treatment:

Drug: EVG

Drug: ARV regimen

Drug: RTV