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Six-year follow-up of HIV-1-infected adults in a clinical trial of antiretroviral therapy with indinavir, zidovudine, and lamivudine
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Objective: To assess virological and immunological responses and toxicity in subjects receiving combination antiretroviral therapy.
Six-year follow-up of HIV-1-infected adults in a clinical trial of antiretroviral therapy with indinavir, zidovudine, and lamivudine
Roy M. Gulick a; Anne Meibohm b; Diane Havlir c; Joseph J. Eron d; Audrey Mosley b; Jeffrey A. Chodakewitz b; Robin Isaacs b; Charles Gonzalez e; Deborah McMahon f; Douglas D. Richman c; Michael Robertson b; John W. Mellors f
aWeill Medical College of Cornell University, New York, bMerck Research Laboratories, West Point, Pennsylvania, cUniversity of California at San Diego and VA San Diego Healthcare System, San Diego, California, the dUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina, the eNew York University School of Medicine, New York and the fUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. cPresent address: San Francisco General Hospital, San Francisco, California, USA.
Design: Six-year follow-up of a single arm of a randomized study of combination antiretroviral therapy.
Methods: HIV-infected, zidovudine-experienced patients originally randomized to receive indinavir, zidovudine, and lamivudine had HIV RNA levels and CD4 cell counts assessed over 6 years. Information was collected by questionnaire from subjects who discontinued the study regimen before 6 years. Both on-study and post-study responses were assessed.
Results: Of 33 subjects, 16 (48%) discontinued before 6 years of follow-up. After 6 years, 16 (53%) and 14 (47%) of 30 contributing subjects had HIV RNA levels < 500 and < 50 copies/ml, respectively, and the median increase in CD4 cell count from baseline for 28 contributing subjects was 268 ¥ 106 cells/l. Treatment-limiting nephrolithiasis occurred in four subjects. Of the 16 subjects who discontinued the study, 12 had post-study questionnaire data available and seven had HIV RNA < 500 copies/ml on a post-study regimen. In an exploratory analysis combining both on-study and post-study data at approximately 6 years, 26 (79%) and 19 (58%) of 33 had HIV RNA levels < 500 and < 50 copies/ml, respectively, and the median increase in CD4 cell count from baseline was 344 ¥ 106 cells/l.
Conclusions: Antiretroviral therapy with indinavir, zidovudine, and lamivudine suppressed HIV viremia and produced continued CD4 cell increases in a majority of subjects for 6 years. Most subjects who discontinued study medications had HIV RNA levels suppressed on post-study therapy. Though based on a small group, this study demonstrates the durable effects of antiretroviral therapy.
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