Controlling Acute or Early HIV Infection With Antiretroviral Drugs, Without a Candidate Vaccine.As Reported Previously, the Candidate Vaccie Was Not Provided by the Maufacturer as Promised

Completed · Has a placebo group

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the role of HIV-specific CD4 T cell responses and immune responses dependent upon these CD4 responses that develop when antiretroviral drugs are started during acute or recent HIV infection, whether these CD4 responses can be enhanced with a therapeutic HIV vaccine (HIV-1 immunogen), and what pattern of HIV-specific immune responses is associated with control of HIV upon discontinuation of antiretroviral drugs during an analytical therapeutic interruption. Participants will be treatment-naive adults with acute or early HIV infection who will choose to start or not start anti-HIV drugs at the beginning of the study. NOTE: In August 2007 we were notified by the manufacturer of the candidate vaccine that they were no longer making the vaccine, and that the vaccine would no longer be available. Unfortunately too few participants have received either the vaccine or placebo to conclude anything about efficacy. No safety problems occurred.

Key facts

Study ID

NCT00238459

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

58

Starts

2005-07-01

Expected to finish

2013-10-01

Last updated by the study team

2013-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute or early HIV infection
• ART naive
• Willing to use acceptable forms of contraception

You may not qualify if…

• Allergy/sensitivity to any components of the vaccine
• Currently involuntarily incarcerated
• Pregnant or breastfeeding

Where it is running

• New York University School of Medicine — New York, New York, United States
• McGill University and University of Montreal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.