Skip to content

The Body Composition Comparing between Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) Containing Regimen in People Living with HIV in Thailand: A Randomize Controlled Trial

The Body Composition Comparing between Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) Containing Regimen in People Living with HIV in Thailand: A Randomize Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260601010
Enrollment
118
Registered
2026-06-01
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

HIV weight gain TAF body composition metabolic

Interventions

TDF 300 MG + 3TC 300 MG + DTG 50 MG 1 tablets oral once daily,FTC 200 MG + TAF 25 MG + DTG 50 MG 1 tablets oral once daily
Active Comparator Drug,Active Comparator Drug
TDF,TAF

Sponsors

The Fogarty International Center at the U.S. National Institutes of Health (NIH)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. PLWH aged between 20-80 years 2. Received TDF/3TC/DTG 3. CrCL more than 50 ml/min 4. No history of bone fracture or osteoporosis or osteopenia 5. No significant change in body weight (weight gain or lose less than 5% in 1 year apart) 6. Able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Currently on latent tuberculosis treatment 2. Pregnancy 3. Inability or unwillingness to adhere to scheduled follow-up visits. 4. Planned relocation outside the study area during the intervention period 5. Active substance abuse or undergoing treatment for alcohol addiction 6. Previous bariatric or significant gastrointestinal surgeries aimed at weight reduction 7. Use of pharmacologic weight-loss agents (oral or injectable) within 3 months prior to enrollment 8. Receiving immunosuppressive therapy including systemic corticosteroids 9. Current hormonal replacement therapy 10. Presence of any medical or psychological condition judged by investigators to interfere significantly with study participation or compliance

Design outcomes

Primary

MeasureTime frame
body fat mass at the beginning of study and at 6 months kg

Secondary

MeasureTime frame
Body weight at the beginning of study and at 6 months kg,waist circumference at the beginning of study and at 6 months cm.,LDL at the beginning of study and at 6 months mg/dl,skeleton muscle mass at the beginning of study and at 6 months kg,FBS at the beginning of study and at 6 months mg/dl,triglyceride at the beginning of study and at 6 months mg/dl,HbA1C at the beginning of study and at 6 months %

Countries

Thailand

Contacts

Public ContactKawisara Krasaewes

Chiang mai university

kawisara.k@cmu.ac.th053936457

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026