Trial information
A Study to Evaluate the Safety and Tolerability of Fuzeon (Enfuvirtide) in Combination With Antiretroviral Agents in Patients With Advanced Human Immunodeficiency Virus (HIV) Infection, Unable to Construct a Viable Treatment Regimen
Status: Completed
Protocol number: MV16721
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label, expanded-access study of Fuzeon plus an antiretroviral regimen to assess safety in patients with advanced HIV infection
Brief summary: This study is designed for HIV patients who are unable to construct an appropriate treatment regimen from the currently available antiretroviral (ARV) agents. Patients with advanced HIV infection will receive Fuzeon in combination with a new ARV regimen based on their prior history and ARV resistance testing. The anticipated time on study treatment is 4 weeks after commercial availability of enfuvirtide in the country in which the patients are treated, and the target sample size is 100-500 individuals.
Target sample size is 277.
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. Serious adverse events; serious AIDS-defining events; and 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:
- HIV-infected adult or adolescents >=16 years of age;
- RNA viral load >=10,000 copies/mL and CD4 lymphocyte count <=100cells/mm³, both while on highly active ARV therapy;
- prior documented ARV resistance, treatment-limited toxicity, and/or >=6 months' prior experience with each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).
Exclusion criteria:
- female patients who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study;
- evidence of ongoing alcohol and/or substance abuse that, in the judgment of the investigator, would result in the patient being unreliable in participating in the study;
- inability to self-inject, unless a reliable caregiver is available to inject;
- evidence of untreated infection, illness aside from HIV, or any other condition that could interfere with taking prescribed ARV treatment.
Gender: Males or Females
Age limits: Min: 16 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 04/05/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
Denmark
- Århus
- Hvidovre
- København
- Odense
Germany
- Berlin
- Bremen
- Frankfurt Am Main
- Grenzach-Wyhlen
- Hamburg
- Hannover
- Köln
- Leipzig
- Nürnberg
- Osnabrück
Italy
Netherlands
Switzerland
- Basel
- Bern
- Geneve
- Lugano
- St. Gallen
- Zürich
