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

The effect of tenofovir disoproxil fumarate (TDF) versus tenofovir alafenamide (TAF) on proximal small intestine – a potential mechanism to explain opposing effects on body weight - Tenentox

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000849-32-FI

Enrollment

Registered

2022-03-25

Start date

2022-05-10

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-positive people who have good and stable treatment response for HIV-medication which includes either tenofovir disoproxil (TDF) or tenoforvir alafenamide (TAF)

Interventions

Trade Name: Viread Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATE CAS Number: 202138-50-9 Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years; HIV-positive on a stable ART including either TDF or TAF for > 6 months; HIV viral load =65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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. 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).	—

Measure

Time frame

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. 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).

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Countries

Finland

Contacts

Public ContactDr Jussi Sutinen

Helsinki University Hospital Infectious Disease Clinic

jussi.sutinen@hus.fi+358407480437

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026