Status:
COMPLETED
Fecal Microbiota Transplantation in HIV
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
American College of Gastroenterology
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Despite antiretroviral therapy (ART), chronic immune activation persists and is a major driver of HIV disease progression and mortality among HIV-infected individuals. Importantly, persistent inflamma...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02256592
Start Date
October 1 2014
End Date
March 1 2017
Last Update
May 4 2017
Active Locations (1)
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1
University of California, San Francisco-San Francisco General Hospital
San Francisco, California, United States, 94110