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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01127204
Eligibility Criteria:
Inclusion Criteria for antiretroviral treatment initiation:
* infant follow-up in one of the trial site
* HIV-1 infection diagnose by RT PCR after 6 weeks of life
* age between 3 and 12 month at the antiretroviral treatment initiation
* naive of antiretrovirals except if received for the prevention of mother to child HIV transmission
* HB\>=7 g/dl, neutrophiles\>750/mm3, creatinin\<3xULN, TGO and TGP\<3xULN
* signed informed consent
Exclusion Criteria for antiretroviral treatment initiation:
* HIV-2 infection or HIV-1/HIV-2 co-infection
* Known intolerance to one of the trial treatment
* HB\<7 g/dl, neutrophiles\<750/mm3, creatinin\>3xULN, TGO or TGP\>3xULN
Inclusion Criteria for randomisation at 12 months in the simplification phase:
* age 24 months at most
* virological success define as 2 consecutive indetectable HIV RNA measured by RT PCR at least 3 months apart.
Exclusion Criteria for randomisation at 12 months in the simplification phase:
* virological failure after the first 12 months of antiretroviral treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
12 Months
Study:
NCT01127204
Study Brief:
Protocol Section:
NCT01127204