TITLE

Randomized, Controlled Trial of Therapy Interruption in Chronic HIV-1 Infection

AUTHOR(S)
Papasavvas, Emmanouil; Kostman, Jary R.; Mounzer, Karam; Grant, Robert M.; Gross, Robert; Gallo, Cele; Azzoni, Livio; Foulkes, Andrea; Thiel, Brian; Pistilli, Maxwell; Mackiewicz, Agnieszka; Shull, Jane; Montaner, Luis J.
PUB. DATE
December 2004
SOURCE
PLoS Medicine;Dec2004, Vol. 1 Issue 3, p218
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Background Approaches to limiting exposure to antiretroviral therapy (ART) drugs are an active area of HIV therapy research. Here we present longitudinal follow-up of a randomized, open-label, single-center study of the immune, viral, and safety outcomes of structured therapy interruptions (TIs) in patients with chronically suppressed HIV-1 infection as compared to equal follow-up of patients on continuous therapy and including a final therapy interruption in both arms. Methods and Findings Forty-two chronically HIV-infected patients on suppressive ART with CD4 counts higher than 400 were randomized 1:1 to either (1) three successive fixed TIs of 2, 4, and 6 wk, with intervening resumption of therapy with resuppression for 4 wk before subsequent interruption, or (2) 40 wk of continuous therapy, with a final open-ended TI in both treatment groups. Main outcome was analysis of the time to viral rebound (5,000 copies/ml) during the open-ended TI. Secondary outcomes included study-defined safety criteria, viral resistance, therapy failure, and retention of immune reconstitution. There was no difference between the groups in time to viral rebound during the open-ended TI (continuous therapy/single TI, median [interquartile range] = 4 [1--8] wk, n = 21; repeated TI, median [interquartile range] = 5 [4--8] wk, n = 21; p = 0.36). No differences in study-related adverse events, viral set point at 12 or 20 wk of open-ended interruption, viral resistance or therapy failure, retention of CD4 T cell numbers on ART, or retention of lymphoproliferative recall antigen responses were noted between groups. Importantly, resistance detected shortly after initial viremia following the open-ended TI did not result in a lack of resuppression to less than 50 copies/ml after reinitiation of the same drug regimen. Conclusion Cycles of 2- to 6-wk time-fixed TIs in patients with suppressed HIV infection failed to confer a clinically significant benefit with regard to viral suppression off...
ACCESSION #
15565245

 

Related Articles

  • Antiviral Briefs.  // AIDS Patient Care & STDs;Oct2005, Vol. 19 Issue 10, p696 

    Reports several developments related to antiviral agents worldwide. Accounts on the reaction of HIV viral load to ritonavir-boosted atazanavir used as monotherapy; Analysis by Great Britain researchers on the benefit of highly active antiretroviral therapy when compared to no treatment in...

  • Therapy for Early HIV Infection: How Far Back Should the Pendulum Swing? Schechter, Mauro // Journal of Infectious Diseases;9/15/2004, Vol. 190 Issue 6, p1043 

    Comments on the optimal time to initiate highly active antiretroviral therapy (HAART) for patients with HIV infection. Recognition of the CD4 cell as the major receptor for HIV; Significance of HAART for improving the prognosis of HIV-seropositive persons; Consideration of initiating HAART for...

  • Mortality in HIV-Seropositive versus -Seronegative Persons in the Era of Highly Active Antiretroviral Therapy: Implications for When to Initiate Therapy. Wang, Cunlin; Vlahov, David; Galai, Noya; Bareta, Joseph; Strathdee, Steffanie A.; Kenrad E. Nelson; Timothy R. Sterling // Journal of Infectious Diseases;9/15/2004, Vol. 190 Issue 6, p1046 

    Background. The optimal time to initiate highly active antiretroviral therapy (HAART) remains unclear. Methods. Five hundred eight-three human immunodeficiency virus (HIV)-seropositive and 920 HIV-seronegative injection drug users (IDUs) were followed from 1997 2000. HIV-seropositive...

  • Denying science.  // Nature Medicine;Apr2006, Vol. 12 Issue 4, p369 

    The article comments on the movement of AIDS denialists in spreading conspiracy theories and misinformation to a susceptible public wary of antiretroviral drugs. Scientists have a very important role to play in explaining the science behind AIDS and showing that antiretroviral drugs can...

  • Tenofovir and Nephrotoxicity. Joshi, Amit; Kraus, Mark // Kidney;Nov/Dec2005, Vol. 14 Issue 6, p255 

    The article provides information on the development of antiretroviral drug tenofovir for the treatment of HIV/AIDS. Tenofovir is an acyclic nucleoside phosphonate in the class of nucleotide reverse transcriptase inhibitors. The drug interrupts DNA synthesis by terminating the elongation of the...

  • ART adherence adequate in Africa although still a global concern.  // PharmacoEconomics & Outcomes News;8/26/2006, Issue 510, p3 

    The article presents information on a meta-analysis of studies that examined levels of adherence to antiretroviral therapy in patients with HIV infection. The analysis revealed that patients in the African studies demonstrated a significantly greater level of adherence than those in the North...

  • Tipranavir. Flexner, Charles; Bate, Guy; Kirkpatrick, Peter // Nature Reviews Drug Discovery;Dec2005, Vol. 4 Issue 12, p955 

    The article focuses on the discovery of Tipranavir, a drug used in the treatment of human immunodeficiency virus (HIV)-1 infection in combination with other antiretroviral agents. The development of antiretroviral regimens in which inhibitors of the HIV-1 protease are combined with nucleoside...

  • No influence of the P-glycoprotein polymorphisms MDR1 G2677T/A and C3435T on the virological and immunological response in treatment naïve HIV-positive patients. Winzer, Ralf; Langmann, Peter; Zilly, Michael; Tollmann, Franz; Schubert, Jörg; Klinker, Hartwig; Weissbrich, Benedikt // Annals of Clinical Microbiology & Antimicrobials;2005, Vol. 4, p3 

    Background: In a retrospective study of HIV-infected patients, we investigated the influence of the MDR1 genotype (G2677T/A and C3435T) on the virological and immunological response of treatment naïve patients. Methods: The MDR1 genotype was analysed from 72 patients in whom antiretroviral...

  • HIV-Associated Lipoatrophy What Are the Kinder, Gentler Agents? Dubé, Michael P. // Clinical Infectious Diseases;1/15/2006, Vol. 42 Issue 2, p281 

    The article informs that lipoatrophy associated with antiretroviral treatment of HIV infection is a serious problem that is associated with significant aesthetic and metabolic derangements. Therapy with thiazolidenediones or switching of therapy to nucleoside reverse-transcriptase inhibitors is...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics