Adults with suppressed HIV on 3-drug ART eligible for a 2-drug switch due to kidney or cardiovascular risk HIV, antiretroviral therapy, dual, sleep quality, dolutegravir, lamivudine, rilpivirine
Conditions
Interventions
This study will investigate the impact of switching from a three-drug to a two-drug antiretroviral regimen (DTG+3TC or DTG+RPV) on sleep quality in people living with HIV. Baseline data, including sle
Experimental Drug,Active Comparator Drug
DTG+RPV,DTG+3TC
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years old 2. People living with HIV (PLHIV) intake 3-drug regimen ARV, with VL <40 copies/mL within 12 months 3. Indication changes 2-drug regimen one of the following 3.1. PLHIV on TDF with eGFR <60 mL/min/1.73m2, on TAF with eGFR <30 mL/min/1.73m2 or Cr rising >30% 3.2. Suspected Fanconi syndrome: proteinuria, glucosuria, hypophosphatemia 3.3. Thai CKD risk score >10% 3.4. PLHIV on ABC with Thai CV risk score >10%
Exclusion criteria
Exclusion criteria: 1. Co-infection with chronic hepatitis B 2. History of resist one of ARV 3. Drug interaction with DTG or 3TC or RPV 4. PLHIV-1 with schizophrenia or depression who screen positive with a PHQ-9 score of more than 5. 5. For pregnant women, menstrual history and contraceptive use will be asked. If there are any irregularities in the menstrual cycle, a urine pregnancy test will be conducted. This also applies to women who are breastfeeding 6. PLHIV-1 with obstructive sleep apnea or those screened using the ANAMAI STOP-BANG questionnaire, with a score of 5 or greater.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality 1 month and 3 months after enrollment Pittsburgh Sleep Quality Index (PSQI) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Body mass index change 3 and 6 months after enrollment Body mass index (BMI) calculation,Depression 1 month and 3 months after enrollment Patient Health Questionnaire (PHQ)-9 score,Kidney function change 3 and 6 months after enrollment Creatinine (Cr) level and estimated glomerular filtration rate (eGFR) ,Metabolic change 6 months after enrollment Fasting blood sugar (FBS) and lipid profiles,Waist circumference change 6 months after enrollment Waist circumference measure | — |
Countries
Thailand
Contacts
Public ContactRujipas Sirijatuphat
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed