trial of probiotics to lower microbial translocation and immune activation in hiv-infected adolescents

Conditions: HIV Infection

Summary: this is a randomized placebo-controlled trial to examine if once daily probiotic therapy will lower serum lps levels and immune activation among hiv-infected youth.

this is a double masked randomized placebo-controlled trial to examine if once daily probiotic therapy will lower serum lipopolysaccharide (lps) levels and immune activation among hiv-infected youth. the study will enroll two cohorts: (1) a cohort of subjects who are not receiving antiretroviral therapy (art) and have absolute cd4 t-cell count greater than 350 cells/ul and quantitative hiv-1 plasma rna (viral load) less than 50,000 copies/ml; and (2) a cohort of subjects who are receiving art and have absolute cd4 t-cell count greater than 350 cells/ul and and quantitative hiv-1 plasma rna (viral load) less than 400 copies/ml.

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

Keywords: hiv infection probiotics