A randomized, dose-finding study with didanosine plus stavudine versus didanosine alone in antiviral-naive, HIV-infected Thai patients
| Autor: | Kiat Ruxrungtham, J. M. A. Lange, Eugene Kroon, Chaiwat Ungsedhapand, R. Van Leeuwen, G. J. Weverling, Supranee Buranapraditkun, Somsong Teeratakulpisarn, Praphan Phanuphak, David A. Cooper, Sasiwimol Ubolyam, Chaiyos Kunanusont |
|---|---|
| Přispěvatelé: | Other departments |
| Rok vydání: | 2000 |
| Předmět: |
Male
medicine.medical_specialty Anti-HIV Agents medicine.medical_treatment Immunology HIV Infections Gastroenterology law.invention Pharmacotherapy Randomized controlled trial law Internal medicine Immunopathology parasitic diseases medicine Humans Immunology and Allergy Prospective Studies Sida Didanosine Chemotherapy biology business.industry Stavudine virus diseases Thailand biology.organism_classification CD4 Lymphocyte Count Surgery Infectious Diseases Toxicity HIV-1 RNA Viral Drug Therapy Combination Female Safety business medicine.drug |
| Zdroj: | AIDS (London, England), 14(10), 1375-1382. Lippincott Williams and Wilkins |
| ISSN: | 0269-9370 |
| DOI: | 10.1097/00002030-200007070-00010 |
| Popis: | To evaluate the safety and efficacy of four different regimens of didanosine (ddI) + stavudine (d4T) in HIV-infected Thais. Prospective, open-label, randomized study. Patients were randomized to four regimens of high and low doses of ddI and d4T or to ddI alone. D4T was added to the ddI-alone arm after week 24. The duration of study was 48 weeks. Seventy-eight patients were randomized (mean CD4 cell count, 255 x 10(6)/l; mean plasma HIV-1 RNA; 4.3 log10 copies/ml). In the intent-to-treat analysis, 78% of patients in the pooled combination arms and 20% of the patients in the ddI alone arm (to which d4T was added after 24 weeks) showed plasma HIV-1 RNA < 500 copies/ml at week 24 (P < 0.001), and 59% versus 53% at week 48, respectively. In addition, the proportion of patients with < 50 HIV-1 RNA copies/ml was 13% versus 7% at week 24 (P = 0.5) and 17% versus 20% at week 48 respectively. At week 24, median CD4 cell count increases from baseline were 101 x 10(6)/l in the pooled combination versus 76 x 10(6)/l in the ddI alone arm (P = 0.78). Logistic regression modeling suggested a correlation between receiving high dose ddI and achieving HIV-1 RNA < 500 copies/ml at week 48 (P = 0.07). The d4T/ddI combination was superior to ddI alone in producing HIV-1 viral suppression. At week 48, > 60% of patients treated with this combination reached HIV-1 RNA levels < 500 copies/ml. Receiving high dose ddI but not d4T may correlate with a better viral suppression |
| Databáze: | OpenAIRE |
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