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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00445146

Run by

Gilead Sciences

People needed

192

Starts

2007-02-01

Expected to finish

2015-03-01

Last updated by the study team

2016-04-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Pheonix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlantis, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Manors, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — North Palm Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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