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. - Tabular View

Tracking Information

First Received Date ^ICMJE

April 16, 2007

Last Updated Date

March 19, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Mean change in CD4 cell count from baseline at week 24.

Change History

Complete list of historical versions of study NCT00461266 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: Change in HIV RNA from baseline at week 24; change in HIV RNA and CD4 cell count between weeks 24 and 48; correlation between CD4 count and HIV RNA; OIs; QoL. Safety: AIDS-defining events; SAEs.

Descriptive Information

Brief Title ^ICMJE

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.

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: enfuvirtide [Fuzeon]
Drug: Antiretroviral therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00461266

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML19355

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP