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

Sponsors and Collaborators:	Hoffmann-La Roche 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

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

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

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 ]

Estimated Enrollment:

238

Study Start Date:

May 2007

Estimated Study Completion Date:

January 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

Show 43 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Trimeris

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:

Hoffmann-La Roche ( Clinical Trials, Study Director )

Study ID Numbers:

ML20837

First Received:

June 18, 2007

Last Updated:

December 2, 2008

ClinicalTrials.gov Identifier:

NCT00488059

Health Authority:

United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:

Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Infection

Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on January 07, 2009