The effect of two related HIV-medicines (TDF and TAF) on small intestine gut wall - could that explain why TDF seems to decrease and TAF to increase body weight
Phase 1
- Conditions
- HIV-positive people who have good and stable treatment response for HIV-medication which includes either tenofovir disoproxil (TDF) or tenoforvir alafenamide (TAF)Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2022-000849-32-FI
- Lead Sponsor
- Helsinki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Age = 18 years; HIV-positive on a stable ART including either TDF or TAF for > 6 months; HIV viral load < 200 copies for = 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare pathology findings including mitochondrial studies in duodenal biopsies of HIV-positive people receiving either TDF or TAF. ;Secondary Objective: To compare the effects of TDF versus TAF on absorption of selected nutrients absorbed from proximal duodenum and circulating markers of intestinal damage and function and microbiota in HIV-positive people.;Primary end point(s): The differences in mitochondrial and pathology studies in proximal duodenum biopsies between study groups (TDF vs TAF).;Timepoint(s) of evaluation of this end point: Once at baseline (this is a cross sectional study).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The differences between study groups (TDF vs TAF) in the blood concentrations of the following: lipids, calcium, phosphate, vitamin D, parathyroid hormone, iron, ferritin, transferrin receptor, folate, beta carotene, vitamin A, thiamine, vitamin E, intestinal fatty acid binding protein (I-FABP), citrulline.<br>Differences in intestinal microbiota between the study groups. ;Timepoint(s) of evaluation of this end point: Once at baseline (this is a cross sectional study).