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.
Phase 4
Withdrawn
- Conditions
- HIV Infections
- Interventions
- Drug: Antiretroviral therapy
- Registration Number
- NCT00461266
- Lead Sponsor
- Hoffmann-La Roche
- 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
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Antiretroviral therapy - 2 Antiretroviral therapy - 1 enfuvirtide [Fuzeon] -
- Primary Outcome Measures
Name Time Method Mean change in CD4 cell count from baseline Week 24
- Secondary Outcome Measures
Name Time Method Change in HIV RNA from baseline Week 24 Change in HIV RNA and CD4 cell count Weeks 24-48 Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs. Throughout study