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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00144105
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent prior to trial participation.
2. HIV-1 infected males or females \>= 18 years of age.
3. No previous ARV therapy.
4. Any CD4+ T lymphocyte count \< 500 cells / µl.
5. HIV-1 viral load \>= 5000 copies/mL at screening.
6. Screening laboratory values that indicate adequate baseline organ function.
7. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening
Exclusion criteria:
1. Female patients of child-bearing potential who:
* have a positive serum pregnancy test at screening or during the study,
* are breast feeding,
* are planning to become pregnant
2. Use of investigational medications within 30 days before study entry or during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00144105
Study Brief:
Protocol Section:
NCT00144105