Abstract | OBJECTIVES: DESIGN: Subjects (n=232) with a CD4 T cell count of > or =200 cells/mm3, plasma HIV-1 RNA levels of > or =10000 copies/ml, and < or =4 weeks of prior nucleoside antiretroviral therapy, were stratified according to baseline plasma HIV-1 RNA level (10000-30000; 30000-100000; or >100000 copies/ml). Subjects received double-blind treatment with either 1200 mg amprenavir twice daily in combination with lamivudine (150 mg twice daily) and zidovudine (300 mg twice daily) ( amprenavir/ lamivudine/ zidovudine) or matched placebo, lamivudine and zidovudine for 16 weeks. Thereafter, subjects with confirmed plasma HIV-1 RNA levels of > or =400 copies/ml could add open-label amprenavir or switch to other antiretrovirals and continue treatment for up to a minimum of 48 weeks. The primary endpoint of the study was defined as the proportion of subjects with plasma HIV-1 RNA of <400 copies/ml at 48 weeks. RESULTS: CONCLUSIONS:
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Authors | J C Goodgame, J C Pottage Jr, H Jablonowski, W D Hardy, A Stein, M Fischl, P Morrow, J Feinberg, C H Brothers, I Vafidis, P Nacci, J Yeo, L Pedneault |
Journal | Antiviral therapy
(Antivir Ther)
Vol. 5
Issue 3
Pg. 215-25
(Sep 2000)
ISSN: 1359-6535 [Print] England |
PMID | 11075942
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-HIV Agents
- Carbamates
- Furans
- RNA, Viral
- Reverse Transcriptase Inhibitors
- Sulfonamides
- Lamivudine
- Zidovudine
- amprenavir
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Topics |
- Adolescent
- Adult
- Anti-HIV Agents
(therapeutic use)
- CD4 Lymphocyte Count
- Carbamates
- Drug Therapy, Combination
- Female
- Furans
- HIV Infections
(drug therapy, virology)
- HIV-1
(physiology)
- Humans
- Lamivudine
(therapeutic use)
- Male
- Middle Aged
- RNA, Viral
(blood)
- Reverse Transcriptase Inhibitors
(therapeutic use)
- Sulfonamides
(therapeutic use)
- Zidovudine
(therapeutic use)
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