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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT00067795
Eligibility Criteria:
Inclusion Criteria for Cohorts A and B:
* HIV-1 infection
* CD4 cell count \> 300 cells/mm3 within 60 days prior to study entry
* Negative pregnancy test within 14 days of starting study
* Agree to use acceptable methods of contraception while in study
Inclusion Criteria for Cohort A (Stable HAART) Only:
* Stable HAART regimen, defined as the suppression of viral load to undetectable levels, for at least 9 months prior to study entry
* Viral load \< 75 copies/ml on at least three occasions within 9 months prior to study entry, with at least one of these values obtained between 6 and 9 months prior to study entry
* No single viral load \>= 75 copies/ml within 9 months prior to study entry
Inclusion Criteria for Cohort B (Efficient Immune Control) Only:
* Not taking any antiretroviral drugs for at least 6 months prior to study entry
* Meets study definition of efficient immune control (generally HIV-1 viral load \< 3,000 copies/ml, with some exceptions)
Exclusion Criteria:
* Pregnancy or breast-feeding
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
* History of an AIDS-defining opportunistic infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00067795
Study Brief:
Protocol Section:
NCT00067795