Trial information
AMICI Study: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients.
Status: No longer recruiting
Protocol number: ML20837
Sponsor: Hoffmann-La Roche; Trimeris Inc.
Company division: Pharmaceutical
Official Scientific Title: An open label study evaluating the antiviral activity and safety of Fuzeon in triple-class experienced HIV-1 infected patients changing their therapy to a standard of care regimen which includes initiating an integrase inhibitor in an expanded access program plus optimized background
Brief summary: This 2 arm study will evaluate the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus optimized background in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study, eligible patients will receive Fuzeon 90mg sc b.i.d. until confirmation of response (min/max = 8/16 weeks). In the second, randomised comparator phase of the study, responders will be randomized to receive Fuzeon either 90mg sc b.i.d. or 180mg qd for a further 24 weeks. Non-responders and virological failures will be terminated from the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 238.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide [Fuzeon]
Primary outcome: 1. Number and percentage of patients with HIV RNA <50 copies/mL Time frame: Week 12 and Week 38
Key secondary outcomes: 1. Mean change in HIV RNA and CD4 from baseline; number and percentage of patients with HIV RNA <=50 copies/mL and <400 copies/mL; number and percentage of patients with >=1 log decline in HIV RNA from baseline. SAEs, ISRs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- HIV-1 infection;
- triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive;
- GSS>=3; nucleosides excluded.
Exclusion criteria:
- adverse clinical or laboratory experience >ACTG Grade 4;
- untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen;
- malignancy requiring chemotherapy or radiotherapy.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2007
Trial registration date: 06/15/2007
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Phoenix, AZ
- Fort Lauderdale, FL
- Miami, FL
- North Palm Beach, FL
- Orlando, FL
- Plantation, FL
- Port St Lucie, FL
- South Miami, FL
- Atlanta, GA
- Macon , GA
- Chicago, IL
- Kansas City, MO
- Newark, NJ
- Briarcliff Manor, NY
- Bronx, NY
- New York, NY
- Rochester, NY
- Ponce, PR
- Santurce, PR
- Dallas, TX
- Fort Worth, TX
- Houston, TX
- Annandale, VA
