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.

Roche

Status and phase: Withdrawn; Phase 4

Conditions: HIV Infections

Treatments: Drug: Antiretroviral therapy; Drug: enfuvirtide [Fuzeon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461266

ML19355

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: enfuvirtide [Fuzeon]

Drug: Antiretroviral therapy

2

Active Comparator group

Treatment:

Drug: Antiretroviral therapy