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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT00531557
Eligibility Criteria:
Inclusion Criteria:
1. HIV-1 infected as documented by a licensed HIV-1 antibody ELISA test
2. At least 18 years of age
3. Currently on an antiretroviral regimen including a ritonavir boosted double protease inhibitor
4. The subject is virologically suppressed with a viral load \< 50 copies/mL for three months or longer
5. The subject has a CD4+ count above 100 cells/mL
6. ≤ Three DRV associated mutations on previous genotypic resistance test -or if no resistance test available, likely to have ≤ four protease inhibitor mutations based on their clinical history
7. If the subject is a woman of child bearing potential, she must agree to use a barrier method of contraception
8. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
Exclusion Criteria:
1. Pregnant or lactating women
2. Individuals with prior darunavir exposure
3. Previous allergic or hypersensitivity reaction to darunavir
4. Clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency)
5. Subjects diagnosed with acute viral hepatitis at screening
6. Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading table (see appendix 3: DAIDS AE grading Table), with the following exceptions unless clinical assessment foresees an immediate health risk to the subject:
* Subjects with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations
* Subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4.
7. Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions: Stable cutaneous Kaposi's Sarcoma (i.e., no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study; Wasting syndrome due to HIV infection.
Note: An AIDS defining illness that is not clinically stabilized for at least 30 days will be considered as currently active.
8. Active drug abuse, including alcohol or recreational drugs, which, in the opinion of the investigator, is expected to interfere with the subject's ability to adhere to the study procedures and treatment regimen. Subjects on a methadone program will be accepted if deemed appropriate by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00531557
Study Brief:
Protocol Section:
NCT00531557