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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents; Vaccines

Criteria

Inclusion Criteria:

• Acute or early HIV infection

• ART naive

• Willing to use acceptable forms of contraception

Exclusion Criteria:

• Allergy/sensitivity to any components of the vaccine

• Currently involuntarily incarcerated

• Pregnant or breastfeeding