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A prospective, randomized trial of structured treatment interruption for patients with chronic HIV type 1 infection.
Clin Infect Dis. 2005 Feb 15; 40(4):594-600.CI

Abstract

BACKGROUND

Structured treatment interruption was evaluated in 74 patients who had been pretreated with antiretrovirals, consisting of 2 nucleoside reverse-transcriptase inhibitors (NRTIs) for 1 year followed by 3 years of highly active antiretroviral therapy containing a protease inhibitor.

METHODS

Patients with a CD4 cell count of > or =350 cells/microL and a plasma viral load of <50 copies/mL were randomized to 3 therapy arms: (1) continuous therapy, (2) CD4 cell count-guided theory, and (3) week-on/week-off (WOWO) therapy. The efficacy and safety of structured treatment interruption and antiretroviral use were evaluated in human immunodeficiency type 1 (HIV-1)-infected patients. The study end points were percentage of patients who developed AIDS or who died and a CD4 cell count of > or =350 cells/microL. Intergroup differences were analyzed using analysis of variance and Kruskal-Wallis tests.

RESULTS

Baseline characteristics at the start of the structured treatment interruption were similar. At week 48, no patient had died, and 1 patient in the WOWO group had an AIDS-defining condition. The proportions of patients with a CD4 cell count of > or =350 cells/microL were 100%, 87%, and 96% in treatment arms 1, 2, and 3, respectively. The percentages of weeks of antiretroviral use were 100%, 41.1%, and 69.8% in arms 1, 2, and 3, respectively. The adverse events were not significantly different among arms (P=.27). Thirty-one percent of patients in the WOWO group experienced virological failure.

CONCLUSION

WOWO therapy maintained a CD4 cell count of > or =350 cells/microL in almost all patients but was associated with high virological failures rates (possibly resulting from previous dual-NRTI therapy), indicating that this strategy is less useful. Receipt of CD4 cell count-guided therapy resulted in comparable clinical outcomes to continuous therapy and may save antiretroviral-associated costs, but this needs to be confirmed by a larger trial.

Authors+Show Affiliations

The HIV Netherlands Australia Thailand Research Collaborative, The Thai Red Cross AIDS Research Center, Bangkok, Thailand. PeterCardiello@post.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15712083

Citation

Cardiello, Peter G., et al. "A Prospective, Randomized Trial of Structured Treatment Interruption for Patients With Chronic HIV Type 1 Infection." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 40, no. 4, 2005, pp. 594-600.
Cardiello PG, Hassink E, Ananworanich J, et al. A prospective, randomized trial of structured treatment interruption for patients with chronic HIV type 1 infection. Clin Infect Dis. 2005;40(4):594-600.
Cardiello, P. G., Hassink, E., Ananworanich, J., Srasuebkul, P., Samor, T., Mahanontharit, A., Ruxrungtham, K., Hirschel, B., Lange, J., Phanuphak, P., & Cooper, D. A. (2005). A prospective, randomized trial of structured treatment interruption for patients with chronic HIV type 1 infection. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 40(4), 594-600.
Cardiello PG, et al. A Prospective, Randomized Trial of Structured Treatment Interruption for Patients With Chronic HIV Type 1 Infection. Clin Infect Dis. 2005 Feb 15;40(4):594-600. PubMed PMID: 15712083.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A prospective, randomized trial of structured treatment interruption for patients with chronic HIV type 1 infection. AU - Cardiello,Peter G, AU - Hassink,Elly, AU - Ananworanich,Jintanat, AU - Srasuebkul,Preeyaporn, AU - Samor,Tarika, AU - Mahanontharit,Apicha, AU - Ruxrungtham,Kiat, AU - Hirschel,Bernard, AU - Lange,Joep, AU - Phanuphak,Praphan, AU - Cooper,David A, Y1 - 2005/01/26/ PY - 2004/07/08/received PY - 2004/09/24/accepted PY - 2005/2/16/pubmed PY - 2006/3/31/medline PY - 2005/2/16/entrez SP - 594 EP - 600 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin. Infect. Dis. VL - 40 IS - 4 N2 - BACKGROUND: Structured treatment interruption was evaluated in 74 patients who had been pretreated with antiretrovirals, consisting of 2 nucleoside reverse-transcriptase inhibitors (NRTIs) for 1 year followed by 3 years of highly active antiretroviral therapy containing a protease inhibitor. METHODS: Patients with a CD4 cell count of > or =350 cells/microL and a plasma viral load of <50 copies/mL were randomized to 3 therapy arms: (1) continuous therapy, (2) CD4 cell count-guided theory, and (3) week-on/week-off (WOWO) therapy. The efficacy and safety of structured treatment interruption and antiretroviral use were evaluated in human immunodeficiency type 1 (HIV-1)-infected patients. The study end points were percentage of patients who developed AIDS or who died and a CD4 cell count of > or =350 cells/microL. Intergroup differences were analyzed using analysis of variance and Kruskal-Wallis tests. RESULTS: Baseline characteristics at the start of the structured treatment interruption were similar. At week 48, no patient had died, and 1 patient in the WOWO group had an AIDS-defining condition. The proportions of patients with a CD4 cell count of > or =350 cells/microL were 100%, 87%, and 96% in treatment arms 1, 2, and 3, respectively. The percentages of weeks of antiretroviral use were 100%, 41.1%, and 69.8% in arms 1, 2, and 3, respectively. The adverse events were not significantly different among arms (P=.27). Thirty-one percent of patients in the WOWO group experienced virological failure. CONCLUSION: WOWO therapy maintained a CD4 cell count of > or =350 cells/microL in almost all patients but was associated with high virological failures rates (possibly resulting from previous dual-NRTI therapy), indicating that this strategy is less useful. Receipt of CD4 cell count-guided therapy resulted in comparable clinical outcomes to continuous therapy and may save antiretroviral-associated costs, but this needs to be confirmed by a larger trial. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/15712083/A_prospective_randomized_trial_of_structured_treatment_interruption_for_patients_with_chronic_HIV_type_1_infection_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/427695 DB - PRIME DP - Unbound Medicine ER -