Document Detail


The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients.
MedLine Citation:
PMID:  17621463     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) to stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV) and an ongoing additional 336-week open-label extension phase.
METHOD: Patients in Brazil, Argentina, and the Dominican Republic who completed the 144-week double-blind phase on TDF were eligible to roll over to the extension phase (weeks 144-480). Results from an interim week 288 analysis are presented.
RESULTS: Eighty-six patients (62% male, 70% white) initially randomized to the TDF arm continued treatment with TDF. At the end of the 144-week, double-blind phase, 85 of the 86 had HIV-1 RNA <400 copies/mL, of whom 84% maintained virologic suppression through week 288. CD4 counts continued to improve with a mean increase of 135 cells/mm(3) from entry into the open-label extension to week 288. No patient discontinued due to renal adverse events. Small changes in bone mineral density at the lumbar spine and hip were seen in the first 48 weeks but were nonprogressive through 288 weeks. Mean limb fat increased from 8.0 kg at week 96 to 8.8 kg at week 288.
CONCLUSION: Through 288 weeks, once-daily TDF+3TC+EFV demonstrated sustained antiretroviral activity with continued immunologic recovery. TDF treatment was not associated with renal adverse events or limb fat loss in antiretroviral-naïve patients.
Authors:
Isabel Cassetti; José Valdez R Madruga; Jamal Muhamad A H Suleiman; Arnaldo Etzel; Lijie Zhong; Andrew K Cheng; Jeffrey Enejosa;
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  HIV clinical trials     Volume:  8     ISSN:  1528-4336     ISO Abbreviation:  HIV Clin Trials     Publication Date:    2007 May-Jun
Date Detail:
Created Date:  2007-07-10     Completed Date:  2007-09-25     Revised Date:  2014-02-06    
Medline Journal Info:
Nlm Unique ID:  100936377     Medline TA:  HIV Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  164-72     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adenine / adverse effects,  analogs & derivatives*,  therapeutic use
Adipose Tissue / pathology
Adult
Anti-HIV Agents / adverse effects,  therapeutic use
Argentina
Benzoxazines / adverse effects*,  therapeutic use*
Bone Density / drug effects
Brazil
CD4 Lymphocyte Count
Dominican Republic
Double-Blind Method
Drug Therapy, Combination
Female
HIV Infections / drug therapy*,  immunology,  virology
Humans
Lamivudine / adverse effects*,  therapeutic use*
Lumbar Vertebrae / pathology
Male
Middle Aged
Organophosphonates / adverse effects*,  therapeutic use*
Pelvic Bones / pathology
RNA, Viral / blood
Viral Load
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Benzoxazines; 0/Organophosphonates; 0/RNA, Viral; 107021-12-5/tenofovir; 2T8Q726O95/Lamivudine; JAC85A2161/Adenine; JE6H2O27P8/efavirenz

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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