Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT00381303
Eligibility Criteria:
Inclusion Criteria:
* Documented HIV infection
* Plasma HIV-RNA \>= 1000 copies/mL
* Must be able to comply with protocol requirements
Exclusion Criteria:
* No prior use of PREZISTA (darunavir), TMC125, enfuvirtide, or tipranavir
* No currently active AIDS defining illness, Category C conditions according to the Center for Disease Control \[CDC\] Classification System for HIV Infection (1993) with the following exceptions, which must be discussed with the Sponsor prior to enrollment: stable cutaneous Kaposi's Sarcoma, Wasting syndrome due to HIV infection
* Not currently using an investigational drug
* Not pregnant or breastfeeding
* No Grade 3 or 4 laboratory abnormality as defined by DAIDS (Division of AIDS, National Institute of Allergy and Infectious Diseases).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00381303
Study Brief:
Protocol Section:
NCT00381303