Trial information
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
Status: Completed
Protocol number: ML19712
Sponsor: Hoffmann-La Roche; Trimeris Inc.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the effect on viral load of a new investigational protease inhibitor with Fuzeon plus a background antiretroviral regimen in triple-class treatment-experienced patients with HIV-1 infection
Brief summary: This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 120.
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. Number and percentage of patients with plasma HIV-1 RNA <50 copies/mL Time frame: Week 24
Key secondary outcomes: 1. Plasma HIV-1 RNA <50 copies/mL Time frame: Weeks 4 and 12
2. Plasma HIV-1 RNA <400 copies/mL Time frame: Weeks 4, 12 and 24
3. Change from baseline in plasma RNA and CD4 Time frame: Weeks 4, 12 and 24
4. Adherence, ISRs, premature discontinuations, SAEs Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- seropositive for HIV-1;
- enrolled in an early access program for a new investigational PI;
- naive to Fuzeon, and the investigational PI;
- treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
Exclusion criteria:
- females who are pregnant or breast-feeding;
- evidence of active, untreated opportunistic infection;
- malignancy requiring chemotherapy or radiotherapy.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/04/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Brisbane
- Melbourne
- South Yarra
- Sydney
United States
- Phoenix, AZ
- Beverly Hills, CA
- Los Angeles, CA
- San Francisco, CA
- Stanford, CA
- Washington, DC
- Fort Lauderdale, FL
- Orlando, FL
- Port St Lucie, FL
- Decatur, GA
- Macon , GA
- Baltimore, MD
- Newark, NJ
- Somers Point, NJ
- Albany, NY
- New York, NY
- Portland, OR
- Philadelphia, PA
- Dallas, TX
- Houston, TX
- Annandale, VA
- Hampton, VA
