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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT01492803
Eligibility Criteria:
Inclusion Criteria:
To be considered eligible for enrollment, an individual must meet the criteria listed below.
* Age 13 years and 0 days to 24 years and 364 days at the time of consent
* Confirmed or suspected to have acquired HIV infection at age 10 years or older
* HIV-1 infection as documented by any FDA-approved ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, HIV-1 DNA, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to pre-entry
* Absolute CD4 T-cell count greater than 350 cells/ul at pre-entry
* Cohort 1 - Not receiving ART and no exposure to ART in the 24 weeks prior to pre-entry: Quantitative HIV-1 plasma RNA (viral load) less than 50,000 copies/ml on two consecutive determinations at least 8 weeks apart in the 24 weeks prior to and including pre-entry
* Cohort 2 - Currently receiving ART and received ART for at least the 24 weeks prior to pre-entry: Quantitative HIV-1 plasma RNA (viral load) less than 400 copies/ml on two consecutive determinations at least 8 weeks apart in the 24 weeks prior to and including pre-entry
* Willingness to refrain from regular use of foods/supplements containing probiotics other than that supplied by the study during the course of study participation
Exclusion Criteria:
To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
* Known hypersensitivity to probiotics
* Active AIDS-defining condition or acute serious illness
* Cohort 1 - Not receiving ART and no exposure to ART in the 24 weeks prior to pre-entry: Any quantitative HIV-1 plasma RNA (viral load) equal to or greater than 50,000 copies/ml during the 24 weeks prior or at pre-entry.
* Cohort 2 - Currently receiving ART and received ART for at least the 24 weeks prior to pre-entry: Any quantitative HIV-1 plasma RNA (viral load) equal to or greater than 400 copies/ml during the 24 weeks prior or at pre-entry
* Known history of inflammatory bowel disease or similar disorder of the GI tract
* Current treatment with immune-modulating or immune-suppressive therapy
* Active malignancy at pre-entry
* Pregnancy
* Grade 3 or higher clinical or laboratory toxicities at the time of randomization
* Regular use of foods or supplements containing probiotics within the 2 weeks prior to randomization (see Appendix V)
* Concurrent participation in the ATN 061, 071, 081, and/or 101 protocols
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
24 Years
Study:
NCT01492803
Study Brief:
Protocol Section:
NCT01492803