Trial information
A Study of Fuzeon (Enfuvirtide) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
Status: Completed
Protocol number: ML18634
Sponsor: Roche Bulgaria EOOD
Company division: Pharmaceutical
Official Scientific Title: Open-label, non randomized clinical trial of safety and tolerability of enfuviritide (Fuzeon®, HIV fusion inhibitor) in patients with advanced HIV1 infection
Brief summary: This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 9.
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. Safety: serious adverse events, serious AIDS-defining events, and all discontinuations
Key secondary outcomes: 1. Overall ISR summary score; AEs and ISR leading to discontinuation; SAEs; deaths; patient satisfaction/preference; adherence.
Inclusion criteria:
- adult or adolescent patients >16 years of age;
- HIV-1 infection;
- CD4 count <100/mm3;
- HIV RNA viral load >10,000 copies/mL while on highly active antiretroviral therapy (HAART);
- documented resistance, treatment-limiting toxicity, and/or >=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.
Exclusion criteria:
- women who are pregnant or breastfeeding;
- patients unable to self-inject;
- active, untreated opportunistic infection.
Gender: Males or Females
Age limits: Min: 16 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
