Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV Infection

In brief

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).

Key facts

Study ID

NCT00708162

Run by

Gilead Sciences

People needed

724

Starts

2008-07-01

Expected to finish

2015-04-01

Last updated by the study team

2016-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
• Documented resistance or at least six months experience prior to screening with two or more different classes of antiretroviral agents
• Stable antiretroviral regimen for at least 30 days prior to screening: however, participants may discontinue the antiretroviral regimen after screening and remain off therapy until baseline at the discretion of the investigator
• Eligible to receive one of the fully-active ritonavir-boosted-PIs, and an allowed second agent
• Normal ECG
• Adequate renal function (estimated glomerular filtration rate according to the Cockcroft-Gault formula ≥ 60 mL/min)
• Hepatic transaminases ≤ 5 × upper limit of normal
• Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
• Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL)
• Serum amylase < 1.5 × the upper limit of the normal range
• Negative serum pregnancy test (females of childbearing potential only)
• Males and females of childbearing potential must agree to use highly effective contraception methods
• Age ≥ 18 years
• Life expectancy ≥ 1 year
• Ability to understand and sign a written informed consent form

You may not qualify if…

• New AIDS-defining condition diagnosed within the 30 days prior to screening
• Prior treatment with any HIV-1 integrase inhibitor
• Participants experiencing ascites
• Participants experiencing encephalopathy
• Females who are breastfeeding
• Positive serum pregnancy test at any time during the study (female of childbearing potential)
• Participants receiving ongoing therapy with any disallowed medication
• Current alcohol or substance use judged by the investigator to potentially interfere with study compliance
• Malignancy other than cutaneous Kaposi's sarcoma or basal cell carcinoma
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
• Participation in any other clinical trial (except for the etravirine or maraviroc expanded access program), without prior approval from sponsor
• Any other clinical condition or prior therapy that would make participants unsuitable for the study
• Known hypersensitivity to study drug, metabolites or formulation excipients

Where it is running

• Health for Life Clinic, PLLC — Little Rock, Arkansas, United States
• Pacific Oaks Medical Group — Beverly Hills, California, United States
• AIDS Healthcare Foundation-Research Center — Beverly Hills, California, United States
• Center for Special Immunology — Fountain Valley, California, United States
• The Living Hope Foundation — Long Beach, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Jeffrey Goodman Special Care Clinic — Los Angeles, California, United States
• University of Southern California, AIDS Clinical Trials Unit — Los Angeles, California, United States
• Peter J. Ruane, MD, Inc. — Los Angeles, California, United States
• Tony Mills, MD Internal Medicine — Los Angeles, California, United States
• Orange Coast Medical Group — Newport Beach, California, United States
• Alameda County Medical Center — Oakland, California, United States
• East Bay AIDS Center — Oakland, California, United States
• Kaiser Permanente — Sacramento, California, United States
• David J. Shamblaw, MD Inc. — San Diego, California, United States
• Metropolis Medical — San Francisco, California, United States
• San Francisco VA Medical Center/UCSF — San Francisco, California, United States
• Connecticut Health Care Group — Glastonbury, Connecticut, United States
• Circle Medical LLC — Norwalk, Connecticut, United States
• The Stamford Hospital - Stamford ID — Stamford, Connecticut, United States
• Whitman-Walker Clinic — Washington D.C., District of Columbia, United States
• The George Washington University Medical Center — Washington D.C., District of Columbia, United States
• South Florida Clinical Research — Atlantis, Florida, United States
• Lifeway , Inc. — Fort Lauderdale, Florida, United States
• Southwest Center for HIV/AIDS — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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