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

Trial end date:
Target enrollment:
Participant gender:
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 3
Accepts Healthy Volunteers?
Lead Sponsor:
Gilead Sciences
Raltegravir Potassium
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

- 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