A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

Roche

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Drug: Optimized Background ARVs

Drug: enfuvirtide [Fuzeon]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00089492

NV17658

Details and patient eligibility

About

This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment

64 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV-1 infected adults or adolescents >=16 years of age;
HIV-1 RNA >=5000 copies/mL;
prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

Exclusion criteria

history of prior use of Fuzeon or T-1249;
female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
current severe illness;
currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.