Indinavir, Nevirapine, Stavudine, and Lamivudine for Human Immunodeficiency Virus–Infected, Amprenavir-Experienced Subjects: AIDS Clinical Trials Group Protocol 373

• Published in: The Journal of infectious diseases Vol. 183; no. 5; pp. 715 - 721
• Main Authors: Gulick, Roy M., Smeaton, Laura M., D'Aquila, Richard T., Eron, Joseph J., Currier, Judith S., Gerber, John G., Acosta, Edward, Sommadossi, Jean-Pierre, Tung, Roger, Snyder, Sally, Kuritzkes, Daniel R., Murphy, Robert L.
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 01.03.2001; University of Chicago Press; Oxford University Press
• Subjects: Adult; AIDS; Amprenavir; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; antiretroviral therapy; Antiretrovirals; Antiviral agents; Antivirals; Biological and medical sciences; Carbamates; CD4 Lymphocyte Count; Clinical trials; Cross-Over Studies; Dose-Response Relationship, Drug; Female; HIV; HIV 1; HIV Infections - drug therapy; HIV Infections - immunology; Human immunodeficiency virus; Human viral diseases; Humans; Indinavir - administration & dosage; Indinavir - therapeutic use; Infectious diseases; Lamivudine - administration & dosage; Lamivudine - therapeutic use; Major Articles; Male; Medical sciences; Nevirapine; Nevirapine - administration & dosage; Nevirapine - therapeutic use; Odds Ratio; Pharmacology. Drug treatments; Prospective Studies; Protease inhibitors; RNA; RNA, Viral - analysis; Safety; Stavudine; Stavudine - administration & dosage; Stavudine - therapeutic use; Sulfonamides - administration & dosage; Sulfonamides - therapeutic use; Time Factors; Treatment Outcome; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load; Virology; Viruses; RNA-directed DNA polymerase; Nevirapine; Toxicity; Non nucleoside compound; Multicenter study; Suppression; Non peptide compound; Stavudine; Reverse transcriptase inhibitor; Antiviral; Pyrimidine nucleoside; Indinavir; Human; Immunopathology; Enzyme; Transferases; Retroviridae; Enzyme inhibitor; Lamivudine; AIDS; Lentivirus; Immune deficiency; Infection; Virus; Peptidases; Nucleotidyltransferases; Treatment; Viral disease; Dideoxynucleoside; Hydrolases; Nucleosidic analog; Human immunodeficiency virus; Amprenavir; Protease inhibitor
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/318820

This prospective, multicenter, open-label study was designed to determine the antiretroviral activity and safety of a 4-drug regimen: 1000 mg indinavir every 8 h with 200 mg nevirapine, 40 mg stavudine, and 150 mg lamivudine, each given twice daily in amprenavir-experienced subjects. The primary end points of the study were the human immunodeficiency virus (HIV) RNA level and CD4 cell count responses. Fifty-six subjects were enrolled and were changed from amprenavir-containing regimens to the 4-drug regimen. Overall, at week 48, 33 (59%) of 56 subjects had HIV RNA levels <500 copies/mL (intent-to-treat analysis, where missing values equal ⩾500 copies/mL) and CD4 cell counts increased by 94 cells/mm3 from baseline. Subjects who had previously taken amprenavir combination therapy were more likely to experience virologic failure than those who had taken amprenavir monotherapy (odds ratio, 7.7; P=.0012). In this study, most subjects who had taken amprenavir-based regimens and who changed to a 4-drug regimen achieved subsequent durable virologic suppression