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

NCT01492803 | Withdrawn DMC

• 1 other identifier: ATN 097
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infection

Keywords

HIV infection; Probiotics

Outcome Measures

Primary Outcomes (1)

• Plasma LPS levels

  To determine if once daily probiotic therapy decreases microbial translocation in HIV-infected youth as measured by changes in plasma LPS.

  32 Weeks

Secondary Outcomes (7)

• Stool colonization with Lactobacillus plantarum

  32 Weeks

• Plasma pro-inflammatory cytokines and macrophage activation

  32 Weeks

• Lymphocyte activation markers

  32 Weeks

• Quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count

  32 Weeks

• Stool microbial composition and genetic diversity

  32 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects randomized to the placebo arm.

Dietary Supplement: Placebo

Probiotics

EXPERIMENTAL

The probiotics use in the study contains two strains of Lactobacillus plantarum. Each dose of the active study agent contains contains 1 g maltodextrin plus the probiotic bacteria Lp299v (5 x 109 cfu) and Lp299 (5 x 109 cfu).

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

Probiotic is a live microorganism that when administered in adequate amounts confer a health benefit on the host. It is classified by the FDA as "generally recognized as safe" (GRAS)

Also known as: No other names.

Probiotics

Placebo DIETARY_SUPPLEMENT

The placebo sticks will contain approximately 1 g maltodextrin

Placebo

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Related Links

• ATN website

MeSH Terms

Conditions

HIV Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• John Sleasman, MD

  University of South Florida

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: December 15, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 28, 2017

Record last verified: 2016-02