BRETT-SMITH H, REYNOLDS L; Interscience Conference on Antimicrobial Agents and Chemotherapy (42nd : 2002 : San Diego, Calif.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2002 Sep 27-30; 42: abstract no. H-162.

Pharmaceutical Research Institute, Bristol-Myers Squibb, Wallingford, CT

BACKGROUND: To compare the safety and antiviral activity of two formulations of stavudine, (d4T) XR vs IR, in combination with lamivudine (3TC) and efavirenz (EFV) in antiretroviral (ARV) naive patients. METHODS: Two randomized, double-blind, multicenter, 48-week studies. Eligible patients were treatment-naive, had HIV RNA >/= 5000 copies/mL (c/mL) in -096 and >/= 2000 c/mL in -099, and a CD4 >/= 100 cells/microL (or >/= 75 if no prior OI). Study participants were randomly assigned to receive 100/75 mg QD XR or 40/30 mg twice-daily (BID) IR formulation (based on weight). All patients received standard doses of 3TC and EFV. RESULTS: In 099, most were non-white (58%) and male (69%). Median baseline HIV RNA and CD4 were 4.8 log[10] c/mL and 277 c/microL, respectively. In 096, the population was mostly white (69%) and male (75%). Median baseline HIV RNA and CD4 were 4.65 log[10] c/mL and 285 c/microL, respectively. CONCLUSIONS: d4T XR was well tolerated in combination with 3TC and EFV and showed comparable efficacy to d4T IR over 48 weeks. The ability to dose d4T QD with other potent ARV QD agents may allow for improved adherence and viral suppression.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Anti-HIV Agents
• HIV
• HIV Infections
• HIV Protease Inhibitors
• HIV Seropositivity
• Humans
• Lamivudine
• Male
• Stavudine

Other ID:

• GWAIDS0027037

UI: 102266661

From Meeting Abstracts