Roche trials database

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:

Hoffmann-La Roche

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 31.

Study phase:

III

Study type:

Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Parallel; Safety/efficacy study

Conditions:

• HIV Infections

Primary outcome:

1. Slope of HIV viral load in HIV-positive patients\n

Key secondary outcomes:

1. Efficacy: HIV-RNA, CD4+, time to failure, proportion of patients with a viral load of <400 and <50 copies/mL.\nSafety: Adverse events; safety laboratory tests\n

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

Anticipated start date:

June, 2005

Trial registration date:

21.12.2005

Date last updated:

04.06.2013

This trial was conducted at the following locations:

Italy

• ALESSANDRIA
• ASTI
• BRESCIA
• FOGGIA
• MILANO
• PADOVA
• ROMA
• TORINO

Link to trial result