Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:December 2011
End Date:December 2012
Contact:Nancy Liu, MPH
Email:nancyliu@westat.com
Phone:(718) 980-3937

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A Randomized Placebo-Controlled Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents


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.

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
We found this trial at
14
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Aurora, CA
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Boston, Massachusetts 02215
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Boston, MA
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Chicago, IL
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Houston, TX
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New Orleans, Louisiana 70112
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New Orleans, LA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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