Trial information
A Study to Collect Safety Data for Fuzeon (Enfuvirtide) in Patients With Human Immunodeficiency Virus (HIV) Infection Who Have Participated in Prior Clinical Studies of Fuzeon
Status: Completed
Protocol number: NV16390
Sponsor: Hoffmann-La Roche Inc; Trimeris Inc.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the safety of Fuzeon plus an antiretroviral therapy of the patient's choice in patients who previously participated in studies of Fuzeon
Brief summary: This study will collect additional safety data for Fuzeon in combination with a background antiretroviral (ARV) regimen of the patient`s choice in those who have previously participated in clinical studies of Fuzeon. Patients may be enrolled through the sites which participated in the original clinical studies, or through their individual primary care HIV physician. The anticipated time on study treatment is related to commercial availability of Fuzeon in the country in which patients are being treated, and the target sample size is <100 individuals.
Target sample size is
225.
Study phase: III
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. Serious adverse events; serious AIDS-defining events; discontinuations; premature withdrawals due to adverse events
Key secondary outcomes: 1. Overall ISR summary score; AEs and ISR leading to discontinuation; SAEs; deaths; patient satisfaction/preference; adherence.
Inclusion criteria:
- adults, adolescents, or children >=6 months of age;
- active participation in or completion of any previous Fuzeon study;
- ability to use Fuzeon in combination with other ARV drugs;
- female patients of child-bearing potential must be prepared to use an effective form of contraception, including a barrier method, for the duration of the study and for 90 days after the last dose of study drug.
Exclusion criteria:
- patients who are pregnant, breastfeeding, or planning to become pregnant during the study;
- evidence of alcohol or drug abuse within 1 year of study entry that, in the investigator's opinion, would result in the patient being unreliable in fulfilling the protocol conditions;
- inability to self-inject, unless a reliable caregiver is available to inject;
- current severe illness aside from HIV, or any other condition which would make the patient unsuitable for the study (in the investigator's opinion).
Gender: Males or Females
Age limits: Min: 6 Months 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:
Brazil
- Campinas
- Porto Alegre
- Rio De Janeiro
- Salvador
- Sao Paulo
Canada
- Calgary, AB
- Edmonton, AB
- Vancouver, BC
- Hamilton, ON
- Ottawa, ON
- Toronto, ON
- Montreal, QC
- Saskatoon, SK
Mexico
