| Autor: |
Antoinette Kenton, Henry H. Balfour, Margaret A. Fischl, James O. Kahn, Keith Henry, Ana Martinez, John P. Phair, Anne Kmack, Song Heng Liou, Martin S. Hirsch, Alejo Erice, Camlin Tierney |
| Rok vydání: |
1998 |
| Předmět: |
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| Zdroj: |
Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology. 19:339-349 |
| ISSN: |
1077-9450 |
| Popis: |
OBJECTIVE The primary objective was to compare the effects of dual or triple combinations of HIV-1 reverse transcriptase inhibitors with respect to survival. The time to new HIV disease progression or death, toxicities, the change in CD4 cells, and plasma HIV-1 RNA concentrations in a subset of study subjects were evaluated. DESIGN This was a multicenter randomized, double-blind, placebo-controlled study. SETTING The study was conducted among 42 adult AIDS Clinical Trials Group sites and 7 National Hemophilia Foundation centers. PATIENTS 1313 HIV-infected patients with CD4 counts < or = 50 cells/mm3 participated in this study, which was conducted from June 1993 to June 1996. INTERVENTION Patients were randomized to one of four daily regimens containing 600 mg of zidovudine: zidovudine alternating monthly with 400 mg didanosine; zidovudine plus 2.25 mg of zalcitabine; zidovudine plus 400 mg of didanosine; or zidovudine plus 400 mg of didanosine plus 400 mg of nevirapine (triple therapy). MAIN OUTCOME MEASURES The main outcome was survival (i.e., time to death). RESULTS A significant difference in survival time was found between the four treatment groups, favoring those assigned to triple therapy (p = .02). A significant difference was also found in the delay of disease progression or death among the four treatment arms favoring the group assigned to triple therapy (p = .002). Baseline CD4 cell counts and plasma HIV-1 RNA concentrations as well as changes of CD4 counts at week 8 predicted survival for subjects in the virology substudy. CONCLUSIONS In the pre-protease inhibitor era, a combination of triple reverse transcriptase inhibitors prolonged life and delayed disease progression in AIDS patients with advanced immune suppression. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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