Evidence that intermittent structured treatment interruption, but not immunization with ALVAC-HIV vCP1452, promotes host control of HIV replication: the results of AIDS Clinical Trials Group 5068.

Abstract

BACKGROUND:

The ability to control human immunodeficiency virus (HIV) replication in vivo in the absence of antiretroviral therapy (ART) is a measure of the efficiency of antiviral immunity. In a study of patients with chronic, ART-suppressed HIV infection, AIDS Clinical Trials Group 5068 investigated the effects of immunization with an exogenous HIV vaccine and pulse exposure to the subject's unique viral epitopes, by means of structured treatment interruptions (STIs), on the dynamics of viral rebound during a subsequent analytical treatment interruption (ATI).

METHODS:

Ninety-seven subjects receiving stable ART with an HIV-1 RNA load <50 copies/mL and CD4(+) T lymphocyte count >400 cells/mm(3) were randomized to undergo continued ART, STIs, ALVAC-HIV vCP1452 immunization, or STIs and ALVAC-HIV vCP1452 immunization.

RESULTS:

Subjects in the 2 STI arms had a significantly longer median doubling time in the period of the initial rise of viral load, a significantly lower median peak viral load, a significantly lower median end-of-ATI viral load set point, and a greater proportion of subjects with an end-of-ATI viral load set point <1,000 copies/mL, compared with the subjects in the 2 arms without STIs. With an immunization schedule of 3 sets of 3 weekly injections, ALVAC-HIV vCP1452 did not affect viral load measures.

CONCLUSIONS:

In this randomized, controlled study of intermittent STI as a therapeutic autoimmunization strategy, evidence of enhanced immunologic control of HIV replication was demonstrated.

• Authors: Jeffrey M Jacobson, R Pat Bucy, John Spritzler, Michael S Saag, Joseph J Eron Jr, Robert W Coombs, Rui Wang, Lawrence Fox, Victoria A Johnson, Susan Cu-Uvin, Susan E Cohn, Donna Mildvan, Dorothy O'Neill, Jennifer Janik, Lynette Purdue, Deborah K O'Connor, Christine Di Vita, Ian Frank, National Institute of Allergy and Infectious Diseases-AIDS Clinical Trials Group 5068 Protocol Team
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 194 Issue 5 Pg. 623-32 (Sep 01 2006) ISSN: 0022-1899 [Print] United States
• PMID: 16897661 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• AIDS Vaccines
• ALVAC vaccine
• Anti-HIV Agents
• Viral Vaccines

Topics

• AIDS Vaccines (administration & dosage, therapeutic use)
• Acquired Immunodeficiency Syndrome (drug therapy, immunology)
• Adult
• Anti-HIV Agents (administration & dosage)
• Clinical Trials as Topic
• Double-Blind Method
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• HIV (drug effects, physiology)
• Humans
• Male
• Middle Aged
• Racial Groups
• Recurrence
• Viral Load
• Viral Vaccines (administration & dosage, therapeutic use)
• Virus Replication (drug effects)