NCT05326971 (TENENTOX) is a Phase 4 clinical trial of gastroscopy in HIV Infections, sponsored by Jussi Sutinen.

Who is sponsoring NCT05326971?

NCT05326971 is sponsored by Jussi Sutinen.

What drugs are being tested in NCT05326971?

Interventions in NCT05326971: gastroscopy.

What condition does NCT05326971 study?

NCT05326971 studies HIV Infections, Weight Gain.

Is NCT05326971 still recruiting?

NCT05326971 is currently status unknown. Last updated 27 March 2023.

Last reviewed 2023-03-27 · How we verify

NCT05326971: TENENTOX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) on Small Intestine Gut Wall

Status unknown Phase 4 Last updated 27 March 2023

What this trial tests

Phase 4 trial testing gastroscopy in HIV Infections in 24 participants. Status unknown.

Timeline

19 January 2023

Primary endpoint
1 June 2025

1 June 2025

Quick facts

Lead sponsor	Jussi Sutinen
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	19 January 2023
Primary completion	1 June 2025
Estimated completion	1 June 2025
Sites	1 location across Finland

Drugs / interventions tested

gastroscopy

Conditions studied

HIV Infections — all drugs for HIV Infections →
Weight Gain — all drugs for Weight Gain →

Sponsor

Jussi Sutinen

Who can join

Adults 20 to 80, any sex, with HIV Infections or Weight Gain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 increasing effect of TAF and / or weight decreasing effect of TDF. When TDF is ingested, it gets absorbed in the beginning of the small intestine. TDF is processed into free tenofovir (TFV) within the enterocytes, whereas TAF is not. The effect of TFV on enterocytes is not known, but in kidney tubular cells TFV seems to damage mitochondria and that seems lead to TDF-associated kidney toxicity. In the present cross sectional study the investigators hypothesize that TDF but not TAF causes damage in the small intestine gut wall and that may lead to poorer absorption of nutrients and opposing effects on body weigh. Twelve stable PLWH who have been treated with TDF for at least past 6 months and 12 PLWH who have similarly been treated with TAF for at least past 6 months will be recruited. The participants will have a gastroscopy done with biopsies taken from the small intestine. These biopsies will be examined for mitochondrial damage and other potential pathological findings. In addition, blood concentrations of several nutrients absorbed from the same part of the small intestine as TDF and blood concentrations of some markers of intestinal damage will be measured.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of 2 Forms of Tenofovir on Duodenal Enterocytes-A Hypothesis for Different Effect of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide on Body Weight and Plasma Lipids.
Kauppinen KJ, Aho I, Sjöblom N, Tynninen O, et al · · 2025 · cited 4× · PMID 39039812 · DOI 10.1093/cid/ciae374

Verify or expand the search:

Other trials of gastroscopy

Trials testing the same drug.

NCT06143410 — Intravenous Lidocaine to Reduce ED50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy · NA · unknown
NCT06363682 — Interventional Reference Levels (IRL) in Digestive Endoscopy · unknown
NCT05956847 — The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric · recruiting
NCT05944887 — Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy. · NA · completed
NCT05829486 — Integrated Pulmonary Index in Gastroscopic Procedures · unknown

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05326971 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jussi Sutinen
Last refreshed: 27 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05326971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing