Trial information
A Study of Viracept (Nelfinavir) in Patients With HIV-1 Infection
Status: Completed
Protocol number: WV16789
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: An open-label study of a new formulation of Viracept to assess gastrointestinal tolerability in patients with HIV-1 infection
Brief summary: This study will assess the gastrointestinal tolerability and acceptability of a new formulation of Viracept (nelfinavir) in patients with HIV-1 infection. Patients either naive or experienced to nelfinavir treatment will be eligible to enter the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
Target sample size is 150.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: nelfinavir[Viracept]
Primary outcome: 1. Patient preference for either Viracept formulation (on Day 42); incidence and duration of GI upset; incidence and duration of moderate/severe diarrhea
Key secondary outcomes: 1. Adverse events; laboratory values; treatment discontinuation
Inclusion criteria:
- adult patients >=18 years of age;
- HIV-1 infection;
- currently stable on an antiretroviral regimen including Viracept for >=8 weeks, with a viral load of <=2000 copies/mL and CD4 cell count of >=200/muL, OR patients with HIV-1 infection initiating nelfinavir treatment, with no restrictions on viral load;
- female patients of childbearing potential must have a negative pregnancy test at screening.
Exclusion criteria:
- pregnant or breastfeeding females;
- females of childbearing potential unwilling to use an effective form of contraception during the study;
- use of an investigational drug within 4 weeks of screening.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
France
- Bordeaux
- Lyon
- Montpellier
- Paris
Germany
Italy
Mexico
Poland
Switzerland
United Kingdom
