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

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

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 09, 2009