Status:
UNKNOWN
The Effect Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) on Small Intestine Gut Wall
Lead Sponsor:
Jussi Sutinen
Collaborating Sponsors:
Helsinki University Central Hospital
University of Helsinki
Conditions:
HIV Infections
Weight Gain
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
Several studies among people living with HIV (PLWH) have shown more weight gain with tenofovir alafenamide (TAF) than with tenofovir disoproxil fumarate (TDF). This difference could be due to weight i...
Detailed Description
Integrase inhibitors (INSTI) and tenofovir alafenamide (TAF) have been associated with increased weight gain in several randomized studies among people living with HIV (PLWH). In most of these studies...
Eligibility Criteria
Inclusion
- Age ≥ 18 year;
- HIV-positive on a stable ART including either TDF or TAF for \> 6 months
- HIV viral load \< 200 copies for ≥ 6 months.
Exclusion
- Known or suspected enteropathies (celiac disease, inflammatory bowel disease)
- Use of any of the following during the previous month: calcium, folic acid, iron, vitamin A, B, E supplements
- Pregnancy.
Key Trial Info
Start Date :
January 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05326971
Start Date
January 19 2023
End Date
June 1 2025
Last Update
March 27 2023
Active Locations (1)
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1
Infectious Disease Clinic, Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00290