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Integrase Inhibitor (MK-0518) Viral Decay

NCT00520897 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-06-05

No results posted yet for this study

Summary

The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma viremia has been successfully suppressed for prolonged periods of time; this pool has emerged as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can further the decay and suppression of HIV-1 in patients who have been virologically suppressed for a prolonged period of time on effective cART (≥ 4 years).

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir (MK0518)

400mg BID; 48 weeks

DRUG

Placebo

400mg QD

PROCEDURE

Leukopheresis

pack of cells as per protocol

PROCEDURE

Sigmoid Biopsy

gut samples as per protocol

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Canadian Immunodeficiency Research Collaborative

    lead OTHER

Principal Investigators

  • Mona Loutfy, MD · Women's College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-02-28
Completion
2011-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT00520897 on ClinicalTrials.gov