Trial information

A Study to Assess the Safety of Fuzeon (Enfuvirtide) in Combination with Oral Antiretroviral Agents in Patients with Advanced Human Immunodeficiency Virus (HIV) Disease, Unable to Construct a Viable Treatment Regimen

Status: Completed

Protocol number: NV16391

Sponsor: Hoffmann-La Roche Inc; Trimeris Inc.

Company division: Pharmaceutical

Official Scientific Title: An open-label study of the safety of Fuzeon plus free choice of antiretroviral therapy in patients with advanced HIV disease and previous multidrug experience who have no viable treatment regimen .

Brief summary: This study will assess the safety of Fuzeon in adults, adolescents, and children with advanced HIV disease with prior multidrug experience who have no viable treatment regimen available from among the approved antiretroviral (ARV) agents. The anticipated time on study treatment is related to commercial availability of T-20 in the country in which patients are being treated, and the target sample size is 100-500 individuals. Target sample size is 750.

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; local injection-site reactions; 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 adults, adolescents, or children with RNA viral load >=10,000 copies/mL and CD4 lymphocyte count <=100 cells/mm3, both while on highly active ARV therapy (HAART);
• inability to construct a viable treatment regimen from among the approved ARV drugs (as per the judgment of the investigator) due to documented drug resistance and/or documented evidence of >6 months' prior experience with each of the 3 classes of approved ARV agents (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

Exclusion criteria:

• female patients who are pregnant, breastfeeding, or who plan to become pregnant during the study;
• evidence of ongoing alcohol or substance abuse that, in the judgement 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 an untreated infection, illness aside from HIV, or any other condition that could interfere with taking prescribed antiretroviral treatment.

Gender: Males or Females

Age limits: Min: 6 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

• Zaventem

Brazil

• Campinas
• Porto Alegre
• Rio De Janeiro
• Salvador
• Sao Paulo

Canada

• Calgary, AB
• Edmonton, AB
• Vancouver, BC
• Halifax, NS
• Ottawa, ON
• Toronto, ON
• Montreal, QC
• Saskatoon, SK

France

• Paris

Germany

• Berlin
• Essen
• München

Italy

• Milano

Mexico

• Mexico City
• Monterrey
• Veracruz

Netherlands

• Woerden

New Zealand

• Christchurch

Portugal

• Amadora

Spain

• Alicante
• Barcelona
• Bilbao
• Valencia

Switzerland

• Bern
• Geneve
• Lausanne
• Lugano
• Zürich

United States

• Cary , NC