AMICI Study: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients.

Condition(s) targeted: HIV Infections

Intervention: enfuvirtide [Fuzeon] (Drug); Optimized ARV background (Drug); Integrase inhibitor (Drug); enfuvirtide [Fuzeon] (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

Official 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Number and percentage of patients with HIV RNA <50 copies/mL

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

SANTURCE 00909, Puerto Rico

PONCE 00717-1563, Puerto Rico

HOBSON CITY, Alabama 36201, United States

PHOENIX, Arizona 85006, United States

LOS ANGELES, California 90028, United States

LOS ANGELES, California 90036, United States

LOS ANGELES, California 90069, United States

STANFORD, California 94305, United States

LOS ANGELES, California 90027, United States

MODESTO, California 95350, United States

WASHINGTON, District of Columbia 20009, United States

ORLANDO, Florida 32803, United States

FORT LAUDERDALE, Florida 33334, United States

SOUTH MIAMI, Florida 33143, United States

PORT ST LUCIE, Florida 34952, United States

NORTH PALM BEACH, Florida 33408, United States

PLANTATION, Florida 33317, United States

FORT LAUDERDALE, Florida 33307, United States

SAFETY HARBOR, Florida 36495, United States

TAMPA, Florida 33614, United States

MIAMI, Florida 33133, United States

FORT MYERS, Florida 39912, United States

MIAMI BEACH, Florida 33139, United States

ATLANTA, Georgia 30309, United States

ATLANTA, Georgia 30318, United States

MACON, Georgia 31201, United States

CHICAGO, Illinois 60657, United States

SILVER SPRING, Maryland 20910, United States

BOSTON, Massachusetts 02215-3318, United States

KANSAS CITY, Missouri 64111, United States

ST LOUIS, Missouri 63139, United States

NEWARK, New Jersey 07102, United States

ROCHESTER, New York 14604, United States

NEW YORK, New York 10003, United States

BRONX, New York 10467-2490, United States

BRIARCLIFF MANOR, New York 10510, United States

ALLENTOWN, Pennsylvania 18102-7017, United States

PHILADELPHIA, Pennsylvania 19107, United States

READING, Pennsylvania 19601, United States

DALLAS, Texas 75246, United States

FORT WORTH, Texas 76104, United States

HOUSTON, Texas 77098, United States

ANNANDALE, Virginia 22003, United States

Starting date: May 2007
Ending date: January 2009
Last updated: June 6, 2008