Virologically-suppressed HIV-infected patients Non-pregnant women living with HIV Dolutegravir, switch, psychiatric events, vitamin D level
Conditions
Interventions
Switch to TDF/3TC/DTG fixed drug combination,continue the current ART eg. 2NRTI/1NNRTI or boosted PIs
Experimental Drug,Active Comparator Drug
Switch to TDF/3TC/DTG fixed drug combination,Continue the current ART
Sponsors
Atlanta Medicare
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral suppression 24 and 48 weeks copies/mL | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4 lymphocyte count 24 and 48 weeks cell/mm3,vitamin D level 0, 24, 48 weeks ng/mL | — |
Countries
Thailand
Contacts
Public ContactSamadhi Patamatamkul
Mahasarakham University
Outcome results
None listed