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A randomized study of the safety and antiretroviral activity of hydroxyurea combined with didanosine in persons infected with human immunodeficiency virus type 1. American Foundation for AIDS Research Community-Based Clinical Trials Network.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 2000 Feb; Vol. 181 (2), pp. 540-7. - Publication Year :
- 2000
-
Abstract
- This randomized open-label trial of human immunodeficiency virus type 1-infected persons compared safety and efficacy for 38 patients receiving hydroxyurea/didanosine combination therapy with findings in 42 persons given didanosine monotherapy for 12 weeks, followed by 12 weeks of hydroxyurea/didanosine combination therapy for all patients. Week 12 on-treatment group comparisons showed a mean decrease in virus load between hydroxyurea/didanosine versus didanosine groups of -0.93 versus -0.74 log10 copies/mL (P=.20); a higher percentage of the hydroxyurea/didanosine group below the assay's detection limit (500 copies/mL), 29% versus 7% (P=.017); and median change in CD4 cells for the hydroxyurea/didanosine versus didanosine group of 0 versus 43 cells/mm3 (P=.045), although median change in CD4 percentage was similar (0.9% vs. 1.2%, P=.64). Week 24 virus load reductions and CD4 cell changes were similar in both groups. Intent-to-treat and on-treatment analyses showed similar results. The hydroxyurea/didanosine combination was well tolerated.
- Subjects :
- Adult
CD4 Lymphocyte Count
DNA, Viral blood
Drug Therapy, Combination
Female
HIV Infections immunology
HIV Infections virology
HIV-1 physiology
Humans
Male
Nucleic Acid Synthesis Inhibitors therapeutic use
Reverse Transcriptase Inhibitors therapeutic use
Viral Load
Anti-HIV Agents therapeutic use
Didanosine therapeutic use
HIV Infections drug therapy
HIV-1 drug effects
Hydroxyurea therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0022-1899
- Volume :
- 181
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 10669337
- Full Text :
- https://doi.org/10.1086/315231