Trial information
A Study of the Safety of Viracept (Nelfinavir) in an Expanded Access Program in HIV-1 Positive Women Who are Pregnant or Who Want to Become Pregnant.
Status: Completed
Protocol number: ML18093
Sponsor: Roche Nederland B.V.
Company division: Pharmaceutical
Official Scientific Title: Open-label Expanded Access Program on safety measures during the treatment of HIV-1 positive pregnant patients or women who want to become pregnant, with Viracept using the 625-mg tablet
Brief summary: This expanded access program will evaluate the safety and tolerability of Viracept (625mg tablet formulation) in HIV-1 positive women who are pregnant or who want to become pregnant. The anticipated time on study treatment is until 4 weeks after commercial availability of Viracept, and the target sample size is <100 individuals.
Target sample size is 5.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: HIV Infections
Intervention type: Drug
Intervention name: nelfinavir[Viracept]
Primary outcome: 1. Serious adverse events and premature withdrawals due to adverse events.
Key secondary outcomes: 1. N/A
Inclusion criteria:
- women who are pregnant or who want to become pregnant;
- women who are eligible to receive treatment with Viracept.
Exclusion criteria:
None specified
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Netherlands
