Skip to content

Effect of Weight Reduction Intervention versus Standard of Care Among PLWH with Dolutegravir-Associated Weight Gain: A Randomized Controlled Trial

Effect of Weight Reduction Intervention versus Standard of Care among People Living with HIV Experiencing Significant Weight Gain from Dolutegravir-Based Regimens: A Randomized Controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240818003
Enrollment
58
Registered
2024-08-18
Start date
2024-08-22
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

weight gain from DTG weight gain DTG weight reduction intervention

Interventions

A primary physician advises on how to lose weight at the time of patient follow-up at OPD ,A nutritionist advises on how to lose weight. after that, each patient will receive phone calls from investig
standard of care ,weight reduction intervention

Sponsors

Faculty of Medicine, CHIANG MAI University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1 age more than 20 years 2 weight gain more than 5% from baseline after receiving dolutegravir at least 6 months 3 can give inform consent 4 understand and use Thai language 5 TMSE more than 24 points

Exclusion criteria

Exclusion criteria: 1 steroid use 2 on TAF 3 underlying schizophrenia 4 alcohol addiction 5 can not walk more than 400 meter 6 can not follow up 7 plan to migrate in research period 8 post gastrectomy for weight reduction 9 on any medication for weight loss 10 weight reduction by themselves more than 4.5 kg in 3 months or as baseline 11 BMI less than 18.5 kg/m2 12 weight more than 158 kg 13 on hormonal therapy 14 having any underlying disease that may obstruct trial

Design outcomes

Primary

MeasureTime frame
weight reduction 6 months measure weight in kg

Secondary

MeasureTime frame
metabolic syndrome parameter 6 months lipid profile,metabolic syndrome parameter 6 months FBS,metabolic syndrome parameter 6 months waist circumference ,metabolic syndrome parameter 6 months BP,body composition 6 months BIA

Countries

Thailand

Contacts

Public ContactPasook Sitthilok

CMU

pasook.sitthilok@cmu.ac.th0909659916

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026