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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT00324103
Eligibility Criteria:
Inclusion Criteria:
* first-line antiretroviral therapy (3 or 4 drugs) for 6 to 18 months (one previous therapy change for toxicity or non-compliance is allowed)
* HIV-RNA level below 400 copies/ml for at least 6 months;
* CD4+ count \> 350 /mm3;
* pre-HAART CD4+ \> 100/mm3
* no previous AIDS diagnosis.
Exclusion Criteria:
* Previous antiretroviral therapy with 1 or 2 drugs (except ARV prophylaxis in pregnancy)
* Pregnancy or breastfeeding
* Previous diagnosis of AIDS
* Grade 3 or 4 adverse event in the 15 days before enrolment
* Neoplasia
* Previous therapy with IL-2, interferon (in the last 2 years) or experimental therapies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00324103
Study Brief:
Protocol Section:
NCT00324103