Trial information
A Study of the Effect of Fuzeon (Enfuvirtide)-Based Therapy on Viral Load in HIV-Positive, Treatment-Naive Patients
Status: Completed
Protocol number: ML18243
Sponsor: Roche S.p.A. Italy
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label, pilot study of a Fuzeon-containing combination therapy compared with standard combination antiretroviral therapy on viral load in treatment-naïve patients with HIV infection
Brief summary: This study will evaluate the effect of Fuzeon-containing combination therapy compared with standard combination antiretroviral therapy on viral load, efficacy and safety in patients with HIV infection who are treatment naive The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
30.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: enfuvirtide[Fuzeon]
Primary outcome: 1. Slope of HIV viral load in HIV-positive patients
Key secondary outcomes: 1. Efficacy: HIV-RNA, CD4+, time to failure, proportion of patients with a viral load of <400 and <50 copies/mL.
Safety: Adverse events; safety laboratory tests
Inclusion criteria:
- adult patients >=18 years of age;
- HIV-positive;
- treatment naive;
- HIV-RNA>10,000 copies/mL;
- late disease or symptomatic HIV infection, with a CD4 count <200 cells/mL, or who have been diagnosed with an AIDS-defining event at any CD4 count.
Exclusion criteria:
- signs of severe illness;
- abnormal liver enzymes (ALT and AST levels >5 times upper limit of normal);
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Alessandria
- Asti
- Brescia
- Milano
- Padova
- Roma
