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

NCT01291459 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-12-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir

MVC/RAL/FTC/TDF 24W followed by MVC/RAL until W48.

Sponsors & Collaborators

  • Association Pour la Recherche en Infectiologie

    lead OTHER

Principal Investigators

  • Laurent COTTE, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01291459 on ClinicalTrials.gov