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

Sponsor:	Hoffmann-La Roche
Collaborator:	Trimeris
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00488059

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: enfuvirtide [Fuzeon] Drug: Optimized ARV background Drug: Integrase inhibitor	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Number and percentage of patients with HIV RNA <50 copies/mL [ Time Frame: Week 12 and Week 38 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	30
Study Completion Date:	February 2009

Arms	Assigned Interventions
1: Experimental	Drug: enfuvirtide [Fuzeon] 90mg sc bid Drug: Optimized ARV background As prescribed Drug: Integrase inhibitor As prescribed
2: Experimental	Drug: Optimized ARV background As prescribed Drug: Integrase inhibitor As prescribed Drug: enfuvirtide [Fuzeon] 180mg sc qd

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488059

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Locations

United States, Alabama

HOBSON CITY, Alabama, United States, 36201
United States, Arizona

PHOENIX, Arizona, United States, 85006
United States, California

LOS ANGELES, California, United States, 90028

LOS ANGELES, California, United States, 90036

LOS ANGELES, California, United States, 90069

STANFORD, California, United States, 94305

LOS ANGELES, California, United States, 90027

MODESTO, California, United States, 95350
United States, District of Columbia

WASHINGTON, District of Columbia, United States, 20009
United States, Florida

ORLANDO, Florida, United States, 32803

MIAMI BEACH, Florida, United States, 33139

SOUTH MIAMI, Florida, United States, 33143

PORT ST LUCIE, Florida, United States, 34952

NORTH PALM BEACH, Florida, United States, 33408

PLANTATION, Florida, United States, 33317

FORT LAUDERDALE, Florida, United States, 33307

SAFETY HARBOR, Florida, United States, 36495

TAMPA, Florida, United States, 33614

MIAMI, Florida, United States, 33133

FORT MYERS, Florida, United States, 39912

FORT LAUDERDALE, Florida, United States, 33334
United States, Georgia

ATLANTA, Georgia, United States, 30309

ATLANTA, Georgia, United States, 30318

MACON, Georgia, United States, 31201
United States, Illinois

CHICAGO, Illinois, United States, 60657
United States, Maryland

SILVER SPRING, Maryland, United States, 20910
United States, Massachusetts

BOSTON, Massachusetts, United States, 02215-3318
United States, Missouri

KANSAS CITY, Missouri, United States, 64111

ST LOUIS, Missouri, United States, 63139
United States, New Jersey

NEWARK, New Jersey, United States, 07102
United States, New York

ROCHESTER, New York, United States, 14604

NEW YORK, New York, United States, 10003

BRONX, New York, United States, 10467-2490

BRIARCLIFF MANOR, New York, United States, 10510
United States, Pennsylvania

ALLENTOWN, Pennsylvania, United States, 18102-7017

PHILADELPHIA, Pennsylvania, United States, 19107

READING, Pennsylvania, United States, 19601
United States, Texas

DALLAS, Texas, United States, 75246

FORT WORTH, Texas, United States, 76104

HOUSTON, Texas, United States, 77098
United States, Virginia

ANNANDALE, Virginia, United States, 22003
Puerto Rico

SANTURCE, Puerto Rico, 00909

PONCE, Puerto Rico, 00717-1563

Sponsors and Collaborators

Hoffmann-La Roche

Trimeris

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20837
Study First Received:	June 18, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00488059 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:

Treatment Experienced

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Enfuvirtide
Virus Diseases
Anti-Retroviral Agents
Integrase Inhibitors
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009