Fecal Microbiota Transplantation in HIV

Completed · Phase 1

Conditions studied: HIV

In brief

Even in individuals treated for HIV, chronic immune activation persists and is associated with increased cardiovascular disease, liver disease, and mortality. HIV-infected individuals have imbalances in the community of intestinal microbes which is thought to contribute to increased and persistent inflammation. The purpose of this study is to examine the safety and durability of fecal microbiota transplant (FMT), the transfer of the bacterial community in stool from a healthy donor, in HIV+ individuals on anti-retroviral therapy. The study will also measure the effects of FMT on immune activation and inflammatory biomarkers in anti-retroviral treated HIV+ individuals.

Key facts

Study ID

NCT02256592

Run by

University of California, San Francisco

People needed

18

Starts

2014-10-01

Expected to finish

2017-03-01

Last updated by the study team

2017-05-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infected men and women 18-75 years of age.
• On continuous anti-retroviral therapy for at least one year.
• Undetectable viral load for at least one year.
• Written informed consent obtained from the subject and ability of the subject to comply with the requirements of the study.

You may not qualify if…

• CD4 T cell count less than 200 cells/mL.
• Recent antibiotic use in the last 3 months.
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Active GI symptoms: inflammatory bowel disease, abdominal pain, hematochezia, or other symptoms requiring medical evaluation and intervention.
• Recent hospitalization or acute medical condition within preceding three months.
• Severe comorbidities: cirrhosis, coagulopathy, heart failure, renal failure, and respiratory failure.
• Testing positive for any of the stool screening test: Clostridium difficile toxin by PCR, routine bacterial culture for enteric pathogens (E coli, Salmonella, Shigella, Yersinia, Campylobacter), culture for Vibrio, fecal Giardia antigen, fecal Cryptosporidium antigen, acid-fast stain for Cyclospora and Isospora, ova and parasites, stool for Rotavirus via EIA.
• History of anaphylaxis.
• Major immunosuppressive medications (e.g., calcineurin inhibitors, exogenous glucocorticoids, biological agents, etc.) or systemic antineoplastic agents.

Where it is running

• University of California, San Francisco-San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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