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Study of the Antiviral and Immunological Effects of Intensification of Suppressive Antiretroviral Therapy With Maraviroc

NCT00703586 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-10-23

No results posted yet for this study

Summary

Hypothesis: Intensification of current ARV regimens with maraviroc will result in more complete suppression of viral replication, particularly in the gastrointestinal mucosa with resultant reduction in markers of immune activation and improved GI immune reconstitution.

Conditions

  • HIV Infections

Interventions

DRUG

Maraviroc

ARM A: Addition of maraviroc to baseline ARV medications for 24 weeks at one of the following doses: * 150 mg orally BID when coadministered with a ritonavir-boosted protease inhibitor * 600 mg orally BID when coadministered with efavirenz or nevirapine ARM B: Addition of an additional NRTI to baseline ARV medications for 12 weeks then cross over to maraviroc intensification for an additional 12 weeks as above: * Addition of abacavir 600 mg orally once daily to a tenofovir containing regimen for 12 weeks then replacing the abacavir with maraviroc. * Addition of an alternate FDA approved NRTI \[such as zidovudine (AZT) or didanosine (ddi)\] at standard oral dosing to a tenofir containing regimen for 12 weeks (if the participant declines abacavir therapy) then replacing the alternate NRTI with maraviroc. * Addition of tenofovir 300 mg daily to an abacavir containing regimen for 12 weeks then replacing the tenofovir with maraviroc.

Sponsors & Collaborators

  • Aaron Diamond AIDS Research Center

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Martin Markowitz, MD · Rockefeller University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00703586 on ClinicalTrials.gov