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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00122668
Eligibility Criteria:
Inclusion Criteria:
* Confirmed HIV-1-infected diagnosis
* Naive of antiretroviral treatment
* Plasma viral load (VL) over 5000 copies/ ml
* CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
* Written, informed consent after approval by the local human research ethics committee
Exclusion Criteria:
* Acute opportunistic infection
* Pregnancy or breast feeding
* Cytotoxic systemic chemotherapy except for Kaposi sarcoma
* Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
* Polynuclear neutrophils below 750/mm3
* Hemoglobin below 8 g/dl
* Platelets below 20 000/mm3
* Creatinine level over 1.5 (upper normal) UN
* ASAT, ALAT, bilirubin level over 3 UN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00122668
Study Brief:
Protocol Section:
NCT00122668