Status:
COMPLETED
Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 (...
Detailed Description
The background regimen will be constructed by the investigator based on viral resistance testing. The fully active PI will be defined by phenotypic resistance analysis. For phenotypic susceptibility, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT00708162
Start Date
July 1 2008
End Date
April 1 2015
Last Update
May 30 2016
Active Locations (180)
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1
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States, 85006
2
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States, 72207
3
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
4
AIDS Healthcare Foundation-Research Center
Beverly Hills, California, United States, 90804