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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00100568
Eligibility Criteria:
Inclusion Criteria:
* HIV-infected
* Have never taken ARV drugs
* CD4 count of 200 cells/mm3 or less within 30 days of study entry if asymptomatic OR CD4 count of 350 cells/mm3 or less within 60 days of study entry if CDC Category A or B clinical condition present OR clinical diagnosis of AIDS, regardless of CD4 count
* Willing to stay in the study area for the duration of the study
* Willing to use acceptable forms of contraception
Exclusion Criteria:
* HIV-2 infected
* Systemic chemotherapy (except interferon) within 6 months prior to study entry
* Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
* Serious illness, including any active AIDS-defining infection, active tuberculosis, malaria, or any illness requiring systemic treatment or hospitalization. People who have completed therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
* Serious psychiatric problems within 60 days of study entry, including depression, suicidal thoughts or attempts, aggressive behavior, or psychosis-like symptoms
* Have taken certain medications within 30 days of study entry
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00100568
Study Brief:
Protocol Section:
NCT00100568