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.

This study has been withdrawn prior to enrollment.

(Slow recruitment)

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00461266

First received: April 16, 2007

Last updated: August 23, 2016

Last verified: August 2016

History of Changes

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 4


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:

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 ]


Enrollment:	0
Study Start Date:	April 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00461266 History of Changes
Other Study ID Numbers:	ML19355
Study First Received:	April 16, 2007
Last Updated:	August 23, 2016
Health Authority:	Australia: South Eastern Sydney Area Health Service

Keywords provided by Hoffmann-La Roche:


Treatment Experienced

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Enfuvirtide HIV Fusion Inhibitors Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 27, 2016

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