Six-year follow-up of HIV-1-infected adults in a clinical trial of antiretroviral therapy with indinavir, zidovudine, and lamivudine

• Published in: AIDS (London) Vol. 17; no. 16; pp. 2345 - 2349
• Main Authors: Gulick, Roy M, Meibohm, Anne, Havlir, Diane, Eron, Joseph J, Mosley, Audrey, Chodakewitz, Jeffrey A, Isaacs, Robin, Gonzalez, Charles, McMahon, Deborah, Richman, Douglas D, Robertson, Michael, Mellors, John W
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 07.11.2003
• Subjects: Adult; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Biological and medical sciences; CD4 Lymphocyte Count; Drug Therapy, Combination; Follow-Up Studies; HIV Infections - drug therapy; HIV Infections - immunology; HIV Infections - virology; HIV-1; Human immunodeficiency virus; Human viral diseases; Humans; Indinavir - adverse effects; Indinavir - therapeutic use; Infectious diseases; Lamivudine - adverse effects; Lamivudine - therapeutic use; Medical sciences; Pharmacology. Drug treatments; RNA, Viral - blood; Treatment Outcome; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load; Zidovudine - adverse effects; Zidovudine - therapeutic use; Skin disease; Design; Immunological investigation; Reverse transcriptase inhibitor; Antiviral; Human; Urinary system disease; Enzyme inhibitor; Retroviridae; AIDS; Method; Lentivirus; Infection; Virus; Peptidases; Nucleotidyltransferases; Chemotherapy; Combined treatment; Nucleosidic analog; Human immunodeficiency virus; Arm; RNA-directed DNA polymerase; Toxicity; antiretroviral therapy; Microbiological investigation; protease inhibitors; Adult; Clinical trial; Pyrimidine nucleoside; Viral load; Indinavir; Kidney disease; Immunopathology; Drug combination; Enzyme; Transferases; Lamivudine; Urinary tract disease; Immune deficiency; Urinary stone; Treatment; Renal lithiasis; Dideoxynucleoside; Viral disease; Hydrolases; Lipodystrophy; Adipose tissue disorders; Zidovudine; Protease inhibitor
• ISSN: 0269-9370
• DOI: 10.1097/00002030-200311070-00009

To assess virological and immunological responses and toxicity in subjects receiving combination antiretroviral therapy. Six-year follow-up of a single arm of a randomized study of combination antiretroviral therapy. 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. 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 x 10(6) 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 x 106 cells/l. 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.