A comparison of stavudine, didanosine and indinavir with zidovudine, lamivudine and indinavir for the initial treatment of HIV-1 infected individuals : Selection of thymidine analog regimen therapy (START II)

• Published in: AIDS (London) Vol. 14; no. 11; pp. 1601 - 1610
• Main Authors: ERON, J. J, MURPHY, R. L, ESINHART, J, SCHOELLKOPF, N, GROSSO, R, STEVENS, M, PETERSON, D, POTTAGE, J, PARENTI, D. M, JEMSEK, J, SWINDELLS, S, SEPULVEDA, G, BELLOS, N, RASHBAUM, B. C
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 28-07-2000
• Subjects: Adolescent; Adult; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretroviral Therapy, Highly Active; Antiviral agents; Biological and medical sciences; CD4 Lymphocyte Count; Didanosine - adverse effects; Didanosine - therapeutic use; Dideoxynucleosides - adverse effects; Dideoxynucleosides - therapeutic use; Female; HIV Infections - drug therapy; HIV Infections - immunology; HIV Infections - virology; HIV Protease Inhibitors - adverse effects; HIV Protease Inhibitors - therapeutic use; HIV-1; Human immunodeficiency virus 1; Humans; Indinavir - adverse effects; Indinavir - therapeutic use; Lamivudine - adverse effects; Lamivudine - therapeutic use; Male; Medical sciences; Nucleoside analogues; Pharmacology. Drug treatments; Reverse Transcriptase Inhibitors - adverse effects; Reverse Transcriptase Inhibitors - therapeutic use; Stavudine; Stavudine - adverse effects; Stavudine - therapeutic use; Thymidine - analogs & derivatives; Viral Load; Zidovudine - adverse effects; Zidovudine - therapeutic use; Human; Immunopathology; Drug combination; Toxicity; Treatment efficiency; Lamivudine; AIDS; Stavudine; Immune deficiency; Infection; Chemotherapy; Treatment; Treatment installation; Viral disease; Dideoxynucleoside; Antiviral; Clinical trial; Didanosine; Therapeutic protocol; Pyrimidine nucleoside; Comparative study; Indinavir
• ISSN: 0269-9370; 1473-5571
• DOI: 10.1097/00002030-200007280-00016

Comparison of stavudine (d4T), didanosine (ddI) and indinavir (IDV) with zidovudine (ZDV), lamivudine (3TC) and IDV in HIV-1 infected patients.
Randomized, open-label.
Fourteen HIV Clinical Research Centers.
Two-hundred and five patients with less than 4 weeks antiretroviral treatment, naive to 3TC and protease inhibitors and with CD4 cell counts > or = 200 x 10(6)/l and plasma HIV-1 RNA levels > or = 10,000 copies/ml.
Stavudine 40 mg and ddI 200 mg twice daily plus IDV 800 mg every 8 h compared with ZDV 200 mg every 8 h or 300 mg twice daily, 3TC 150 mg twice daily plus IDV.
The proportion of patients with plasma HIV-1 RNA levels < 500 copies/ml and < or = 50 copies/ml and changes in CD4 cell counts were compared.
In an analysis of the primary endpoint, 61% of patients on d4T + ddI + IDV and 45% of patients on ZDV + 3TC + IDV had all HIV-1 RNA values obtained between weeks 40 and 48 < 500 copies/ml [95% confidence interval (CI) for the difference between proportions, 1.7-30.3%; P = 0.038]. In an intent-to-treat analysis, the percentage of all patients randomized with all HIV-1 RNA levels < 500 copies/ml between 40 and 48 weeks were 53% for the d4T + ddI + IDV arm and 41% for the ZDV + 3TC + IDV arm (95% CI, -1.4% to 25.7%; P = 0.068). At 48 weeks 41% and 35% were < or = 50 copies/ml for the stavudine- and ZDV-containing arms respectively (P > 0.2). The median time-weighted average increases in CD4 cells count over 48 weeks were 150 x 10(6)/l cells for the d4T arm and 106 x 10(6)/l cells for the ZDV arm (P= 0.001). The occurrence of serious adverse events was not significantly different between arms.
The combination of stavudine, ddl and IDV resulted in potent antiretroviral effects over a 48-week period, comparable or superior to zidovudine, 3TC and IDV supporting the use of stavudine, ddI and a protease inhibitor as an initial antiretroviral treatment.