Trial information
A Study to Evaluate the Safety and Efficacy of Adding Fuzeon (Enfuvirtide) to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients with Prior Treatment Experience
Status: Completed
Protocol number: MV18406
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of Fuzeon plus a highly active antiretroviral therapy (HAART) compared with HAART alone on viral load suppression and safety in patients currently on antiretroviral therapy
Brief summary: This 2 arm study will assess the efficacy of Fuzeon added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression. Patients who wish to enroll in the study must currently be on an antiretroviral (ARV) regimen. Patient and physician will select the oral HAART regimen based on the patient's prior experience with ARV. Eligible patients will be randomized either to the HAART arm, or to HAART + Fuzeon 90mg sc bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Target sample size is
100.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide [Fuzeon]
Primary outcome: 1. Viral suppression Time frame: Week 24 and 48
2. Time to loss of viral response Time frame: Throughout study
3. Pneumonia, SAEs, ADEs Time frame: Throughout study
Key secondary outcomes: 1. Viral load and CD4 evaluations Time frame: Week 24 and 48
Inclusion criteria:
- HIV-1 infected adults >=18 years of age;
- currently on ARV therapy;
- previously treated with 2 or 3 different ARV classes;
- HIV-1 RNA >=1,000 copies/mL;
- CD4 lymphocyte count >=200cells/mm3;
- females of childbearing potential must be willing to use a reliable form of effective barrier contraception for the duration of the study and for 30 days after the last dose of study drug.
Exclusion criteria:
- history of prior use of enfuvirtide or T-1249;
- women who are pregnant, breastfeeding or planning to become pregnant during the study;
- active, untreated opportunistic infection;
- patients on treatment interruption, or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons either than toxicity management.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 04/05/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
France
Germany
Italy
Mexico
Spain
United States
- Cleveland, OH
- Austin, TX
- Dallas, TX
