ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00461266

Purpose

This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy, or to continue their current antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition	Intervention	Phase
HIV Infections	Drug: enfuvirtide [Fuzeon] Drug: Antiretroviral therapy	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-Infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Mean change in CD4 cell count from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in HIV RNA from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Change in HIV RNA and CD4 cell count [ Time Frame: Weeks 24-48 ] [ Designated as safety issue: No ]
Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
Experimental: 1	Drug: enfuvirtide [Fuzeon] 90mg sc bid Drug: Antiretroviral therapy As prescribed
Active Comparator: 2	Drug: Antiretroviral therapy As prescribed

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;
documented chronic HIV infection;
currently receiving a stable antiretroviral regimen;
CD4 cell count <250 cells/mm3;
HIV RNA viral load <400 copies/mL for >12 months.

Exclusion Criteria:

prior exposure to Fuzeon;
prior non-adherence to antiretroviral treatment regimens;
active opportunistic infection;
currently taking, or anticipated to take during the study, any immunomodulator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461266

Locations

Australia

Carlton, Australia

Darlinghurst, Australia

Melbourne, Australia

Miami, Australia

Perth, Australia

South Yarra, Australia

Sydney, Australia

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00461266 History of Changes
Other Study ID Numbers:	ML19355
Study First Received:	April 16, 2007
Last Updated:	March 19, 2008
Health Authority:	Australia: South Eastern Sydney Area Health Service

Keywords provided by Hoffmann-La Roche:

Treatment Experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Slow Virus Diseases
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012