Trial information
A Study of Fuzeon (Enfuvirtide) in Patients With Advanced HIV Infection
Status: No longer recruiting
Protocol number: ML17819
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: An open-label study to assess the safety and tolerability of Fuzeon in combination with a free choice of antiviral regimen in Thai patients with advanced HIV infection.
Brief summary: This study will assess the safety and tolerability of Fuzeon (90mg sc bid) in Thai patients with advanced HIV-1 disease. Eligible patients will have received treatment with, and failed on, regimens containing at least one product from each antiretroviral class, or will have experienced intolerance to previous antiretroviral regimens. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals. Target sample size is
30.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide[Fuzeon]
Primary outcome: 1. SAEs, serious AIDS defining events, discontinuations.
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- HIV-1 infected patients, >=16 years of age;
- >=6 months experience of PIs, NRTIs and NNRTIs;
- genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens.
Exclusion criteria:
Gender: Males or Females
Age limits: Min: 16 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2004
Trial registration date: 06/16/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Thailand
- Bangkok
- Chiang Mai
- Nonthaburi
