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.

TitleEvidence 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.
Publication TypeJournal Article
Year of Publication2006
AuthorsJacobson JM, R Bucy P, Spritzler J, Saag MS, Eron JJ, Coombs RW, Wang R, Fox L, Johnson VA, Cu-Uvin S, Cohn SE, Mildvan D, O'Neill D, Janik J, Purdue L, O'Connor DK, Di Vita C, Frank I
Corporate AuthorsNational Institute of Allergy and Infectious Diseases-AIDS Clinical Trials Group 5068 Protocol Team
JournalJ Infect Dis
Volume194
Issue5
Pagination623-32
Date Published2006 Sep 1
ISSN0022-1899
KeywordsAcquired Immunodeficiency Syndrome, Adult, AIDS Vaccines, Anti-HIV Agents, Clinical Trials as Topic, Continental Population Groups, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, HIV, Humans, Male, Middle Aged, Recurrence, Viral Load, Viral Vaccines, Virus Replication
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.

DOI10.1086/506364
Alternate JournalJ. Infect. Dis.
PubMed ID16897661
Grant ListAI25868 / AI / NIAID NIH HHS / United States
AI25879 / AI / NIAID NIH HHS / United States
AI25903 / AI / NIAID NIH HHS / United States
AI25924 / AI / NIAID NIH HHS / United States
AI27658 / AI / NIAID NIH HHS / United States
AI27664 / AI / NIAID NIH HHS / United States
AI27665 / AI / NIAID NIH HHS / United States
AI32783 / AI / NIAID NIH HHS / United States
AI38855 / AI / NIAID NIH HHS / United States
AI38858 / AI / NIAID NIH HHS / United States
AI46370 / AI / NIAID NIH HHS / United States
AI46381 / AI / NIAID NIH HHS / United States
AI50410 / AI / NIAID NIH HHS / United States
P30 AI27767 / AI / NIAID NIH HHS / United States
RR00032 / RR / NCRR NIH HHS / United States
RR00040 / RR / NCRR NIH HHS / United States
RR00044 / RR / NCRR NIH HHS / United States
RR00046 / RR / NCRR NIH HHS / United States
RR00096 / RR / NCRR NIH HHS / United States
U01AI38858 / AI / NIAID NIH HHS / United States