Maraviroc (CCR5) Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients

Summary

The purpose of this study is to determine if Maraviroc administration can decrease IRIS incidence in HIV infected patients initiating ARV therapy.

Conditions

• Immune Reconstitution Inflammatory Syndrome
• HIV
• HIV Infections

Interventions

DRUG

maraviroc

Maraviroc 600mg po BID every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops. Efavirenz 600 mg qd every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops. Tenofovir/Emtricitabine 300/200 mg qd from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops.

DRUG

Placebo

Placebo tablets po BID every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops. Efavirenz 600 mg qd every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops. Tenofovir/Emtricitabine 300/200 mg qd from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops.

Sponsors & Collaborators

• University of Witwatersrand, South Africa

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• The Wistar Institute

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  lead OTHER

Principal Investigators

• Ian Sanne, MBBCH, FCP · University of the Witwatersrand. Themba Lethu Clinic.

• Michael M. Lederman, MD · Center for AIDS Research. Case Western Reserve University

• Luis J Montaner, M.Sc. · HIV-1 Immunopathogenesis Laboratory. The Wistar Institute

• Livio Azzoni, MD, PhD · HIV-1 Immunopathogenesis Laboratory. The Wistar Institute

• Juan G Sierra Madero, MD · Insituto Nacional de Nutricion de Ciencias Medicas y Nutricion Salvador Zubiran

• Susan Ellenberg, Ph.D. · Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine

• Irini Sereti, M.D., MHS · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2013-03-31

Completion

2013-04-30

Countries

• United States
• Mexico
• South Africa

Study Locations