Trial information
A Study to Evaluate the Safety and Efficacy of Switching Human Immunodeficiency Virus (HIV)-infected Patients From a Toxicity-Causing Antiretroviral (ARV) Agent to Fuzeon
Status: Completed
Protocol number: MV18220
Sponsor: F. Hoffmann-La Roche Ltd.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the safety of switching from a toxicity-causing antiretroviral (ARV) therapy to Fuzeon in patients with ARV treatment-limiting toxicities
Brief summary: This study is designed for patients with a history of treatment-related toxicities on ARV therapy or who are currently experiencing toxicities on ARVs. The ability of Fuzeon to improve the adverse events related to ARV therapy will be assessed. Patients will switch from their primary toxicity-causing ARV to Fuzeon. The anticipated time on study treatment is 3-Â12 months and the target sample size is 100-500 individuals.
Target sample size is 125.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide[Fuzeon]
Primary outcome: 1. Grading of severity of and assessment of change in toxicity;adverse events, laboratory tests, discontinuations, deaths
Key secondary outcomes: 1. Proportion of patients who maintained or improved viral load response and CD4 T-lymphocyte count from baseline. Quality of life
Inclusion criteria:
- HIV-1 infected adults who have previously received all 3 classes of oral ARV (ie, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors);
- prior experience limited to <=12 ARVs in HIV treatment;
- patients who are still continuing on the toxicity-causing ARV or who have interrupted treatment (within 4 weeks prior to start of study) due to any acute ARV-related toxicity may be eligible if they are willing to recommence their regimen combination excluding the primary toxicity causing ARV, while adding Fuzeon to that regimen.
Exclusion criteria:
- prior exposure to enfuvirtide;
- female patients who are pregnant, breastfeeding, or who plan to become pregnant;
- evidence of ongoing alcohol 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: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 04/05/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Canada
Germany
- Bochum
- Düsseldorf
- Essen
- Frankfurt Am Main
- Hamburg
- Hannover
- Heidelberg
- Koblenz
- Köln
- Mainz
- München
- Osnabrück
- Stuttgart
Italy
Poland
Romania
Spain
- Alicante
- Barcelona
- Bilbao
- Madrid
- Santa Cruz de Tenerife
- Santander
