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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT00053404
Eligibility Criteria:
Inclusion Criteria:
* HIV-infected for at least 6 months prior to study entry
* Documented pretherapy or off-therapy viral load of more than 10,000 copies/ml on at least 2 occasions or more than 20,000 copies/ml on at least 1 occasion
* At least a 70% reduction in plasma HIV RNA levels from pretherapy baseline
* Stable highly active antiretroviral therapy (HAART) regimen for at least 4 months prior to study entry
* HIV viral load of 200 to 10,000 copies/ml for 3 months prior to study entry
* CD4 count greater than 100 cells/mm3 and a nadir CD4 count less than 500 cells/mm3
* Virologic failure as defined by DHHS guidelines on at least one HAART regimen prior to the study entry HAART regimen
* Documented adherence to antiretroviral therapy
* Two major resistance mutations to at least two antiretroviral drug classes
Exclusion Criteria:
* Significant toxicity on current HAART regimen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00053404
Study Brief:
Protocol Section:
NCT00053404