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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT01192035
Eligibility Criteria:
Inclusion Criteria:
* Antiretroviral treatment (ART) naïve HIV-1 infected patients. Women receiving ART during pregnancy can be included.
* Age ≥ 18 years
* CD4+ cell count ≤ 350 cells/µL and/or
* Clinical signs of immune suppression (WHO clinical stage 3 or 4) irrespective of CD4+ cell count.
Exclusion Criteria:
* Tuberculosis (TB) treatment with rifampicin at the time of enrolment.
* Co-infection with HIV-2.
* Grade 3 or 4 alanine transaminase (ALAT) elevation (\>5 times upper normal limit).
* Patients with cerebral disturbances that complicates the ability to give informed consent or follow the treatment regime.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01192035
Study Brief:
Protocol Section:
NCT01192035