Randomized-controlled trial evaluating the outcome between switching to tenofovir disoproxil fumarate(TDF)/lamivudine(3TC)/dolutegravir(DTG) versus maintaining the current NNRTI or boosted-PI -containing regimen in non-virologic failure HIV infection in Thailand
- Conditions
- Virologically-suppressed HIV-infected patientsNon-pregnant women living with HIVDolutegravir, switch, psychiatric events, vitamin D level
- Registration Number
- TCTR20210409003
- Lead Sponsor
- Atlanta Medicare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
1. Thai adult age > 18 year-old
2. Positive HIV-1 antibody or plasma HIV-1 viral load
3. Currently treated with 2NRTI/1NNRTI or boosted-PIs
4. Willing to participate throughout 48 weeks period and have a regular follow-up at Suddhavej hospital
1. Women with childbearing age who wish to be pregnant in the next 52 weeks period
2. Women with childbearing age who deny contraception
3. Pregnant women
4. Documented HIV resistance
5. History of DTG hypersensitivity or the following substances: D-Mannitol, Microcystalline Cellulose, Povidone, Croscarmellose Sodium, Sodium Stearyl Fumarate, Talc, white film coat
6. Virologic failure
7. Creatinine clearance (CKD-EPI Asia) < 60 ml/min
8. Cirrhosis child B-C
9. Alanine aminotransferase (ALT) >= 5X of upper limit or ALT >= 3X +total bilirubin >= 1.5X of upper limit
10. Currently treated tuberculosis
11. Currently on >= 1000 mg of metformin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method