Trial information
A Study to Assess Fuzeon (Enfuvirtide) in Human Immunodeficiency Virus (HIV)-infected Subjects With Renal Impairment
Status: Completed
Protocol number: NP17586
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the pharmacokinetics of Fuzeon in patients with HIV-1 infection and renal impairment
Brief summary: This study will evaluate if renal impairment and hemodialysis alter the pharmacokinetic effects of Fuzeon in subjects with HIV. The anticipated time on study treatment is <3 months and the target sample size is <100 individuals.
Target sample size is
24.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Pharmacokinetics study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide[Fuzeon]
Primary outcome: 1. PK parameters; analysis of dialysate
Key secondary outcomes: 1. Vital signs, clinical laboratory tests, adverse events, injection site reactions
Inclusion criteria:
- adults between 18 and 64 years of age with HIV-1 infection;
- renal impairment or no renal impairment. Renally-impaired subjects must have reasonably stable renal function.
Exclusion criteria:
- current Fuzeon treatment;
- current or previous treatment with tenofovir (other than hemodialysis patients);
- active opportunistic infections.
Gender: Males or Females
Age limits: Min: 18 Years Max: 64 Years
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:
United States
- Torrance , CA
- Fort Lauderdale, FL
- Sarasota , FL
- Somers Point, NJ
- Philadelphia, PA
- Dallas, TX
