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Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir

NCT00976404 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-09-12

Study results available
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Summary

The objective of this study is to discover a new approach in which human immunodeficiency virus (HIV) can be eradicated from an infected individual by intensified antiretroviral treatment coupled with immunomodulation. The hypothesis is that eradication is possible only if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory agent that simultaneously attack the viral reservoirs.

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

DNA + HIV-rAd5 vaccine

4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5)

DRUG

ART intensification (raltegravir)

raltegravir 400 mg PO BID for 56 weeks

DRUG

ART intensification (maraviroc)

maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks

Sponsors & Collaborators

  • Objectif Recherche Vaccins SIDA

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Pfizer

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Robert L. Murphy

    lead OTHER

Principal Investigators

  • Robert Murphy, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-07-31
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00976404 on ClinicalTrials.gov