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.

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00461266
• Other study ID #: ML19355
• Status: Withdrawn
• Phase: Phase 4
• First received: April 16, 2007
• Last updated: August 23, 2016
• Start date: April 2007
• Est. completion date: January 2008

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: South Eastern Sydney Area Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• enfuvirtide [Fuzeon]
90mg sc bid
• Antiretroviral therapy
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in CD4 cell count from baseline		Week 24	No
Secondary	Change in HIV RNA from baseline		Week 24	No
Secondary	Change in HIV RNA and CD4 cell count		Weeks 24-48	No
Secondary	Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.		Throughout study	No