A multicenter, randomised, double-blind, double-dummy, phase III study of the safety and efficacy of Ritonavir-boosted Elvitegravir (EVG/r) versus Raltegravir (RAL) each administered with a background regimen in HIV-1 infected, antiretroviral treatment-experienced adults. - ND

Conditions: HIV-1 infection
MedDRA version: 9.1Level: LLTClassification code 10020192Term: HIV-1

Registration Number: EUCTR2007-004225-26-IT

Lead Sponsor: Gilead Sciences Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

. Plasma HIV-1 RNA levels > or = 1000 copies/ml at screening . Documented viral resistance or at least six months experienced prior to screening with two or more different classes of antiretroviral agents. . Stable current antiretroviral regimen for at least 30 days prior to screening . No prior treatment with any HIV-1 integrase inhibitor.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. A new AIDS-defining condition diagnosed within the 30 days prior to screening . Prior treatment with any HIV-1 integrase inhibitor . Subjects experiencing ascites or encephalopathy . Females who are breastfeeding . Positive serum pregnancy at any time during the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess non-inferiority of a regimen containing Ritonavir-boosted Elvitegravir vs Raltegravir, each administered with a background regimen in HIV-1 infected, antiretroviral treatment-experienced adult subjects as determined by the proportion of subject achieving and mantaining confirmed HIV-1 RNA < 50 copies/ml through week 48.;Secondary Objective: To evaluate the efficacy, safety and tolerability of the two treatment arms through 48 weeks of treatment.;Primary end point(s): Efficay endpoint: proportion of subjects achieving and mantaining confirmed HIV-1 RNA < 50 copies/ml through week 48

Secondary Outcome Measures