LALEZARI JP, HENRY K, O'HEARN M, LEFEBVRE E, MONANER J, PILIERO P, WALMSLEY S, CHUNG J, FANG L, DELEHANTY J, SALGO M; The TORO 1 Study Group; 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-1074.

Quest Clinical Research, San Francisco, CA

BACKGROUND: TORO 1 (T-20 vs Optimized Regimen Only) is a Phase III study of enfuvirtide, the first Fusion Inhibitor which targets HIV gp41, inhibiting viral fusion to host cells. METHODS: Patients with >/= 6 months prior experience with 3 classes of ARVs, and HIV-1 RNA >/= 5,000 copies/mL selected an OB regimen of 3-5 ARVs based on prior history and BL genotypic (GT) and phenotypic (PT) viral resistance. Patients were randomized 2:1 to enfuvirtide (90 mg SC BID) + OB or OB alone. RESULTS: The primary 24 week analysis contained 491 patients. Median BL HIV-1 RNA was 5.2 log 10 copies/mL, and CD4 count 80 cells/mm3. 54% of patients had CD4 counts <100 cells/mm3 and 61% of patients had HIV RNA >100,000 copies/mL. 69% of BL viral isolates from patients had PT sensitivity to Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• CD4 Lymphocyte Count
• Clinical Protocols
• Drug Therapy, Combination
• HIV Envelope Protein gp41
• HIV Infections
• HIV Seropositivity
• Humans
• Peptide Fragments
• Viral Load
• drug therapy
• enfuvirtide
• immunology
• therapy

Other ID:

• GWAIDS0027523

UI: 102267147

From Meeting Abstracts