Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients — NNNB  

HIV Clinical Trial

Official title: Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus

Status Active, not recruiting

Clinical Trial Summary

Background and Rationale

Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.

Hypothesis

Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.

Clinical Trial Description

Objectives:

• To establish the ability of a Maraviroc-Raltegravir combination to maintain HIV-1 viral load < 50 copies/ml at week 48 in naive patients infected by CCR5 HIV-1, following an initial 6 month phase of Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination (Intent to treat and strategy analysis)

• To study CD4 progression from baseline to week 48

• To study the time to virological failure during the simplification phase of the study (from week 24 to week 48)

• To study the proportion of patients with HIV RNA < 50 copies/ml at each time point

• To study the kinetics of viral load decrease from baseline to week 12

• To study the kinetics of proviral DNA decrease from baseline to week 12, 24, 36 and 48

• To study the clinical and biological tolerance of Maraviroc-Raltegravir combination through week 48

Study Design/ Clinical Plan

Pilot, multicenter, national, uncontrolled study ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

• NCT number: NCT01291459
• Study type: Interventional
• Source: Association Pour la Recherche en Infectiologie
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2011
• Completion date: December 2015