Trial information
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.
Status: Terminated
Protocol number: ML19355
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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. Target sample size is 40.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide [Fuzeon]
Primary outcome: 1. Mean change in CD4 cell count from baseline Time frame: Week 24
Key secondary outcomes: 1. Change in HIV RNA from baseline Time frame: Week 24
2. Change in HIV RNA and CD4 cell count Time frame: Weeks 24-48
3. Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs. Time frame: Throughout study
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: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 04/17/2007
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Carlton
- Darlinghurst
- Melbourne
- Miami
- Perth
- South Yarra
- Sydney
