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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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 (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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Elvitegravir; Raltegravir Potassium; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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