HIV/AIDS
Conditions
Interventions
Switch to 2DR
Sponsors
University of Nairobi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able and willing to understand and comply with the protocol requirements, instructions and restrictions 2. Able and willing to give informed consent 3. Have been randomised to the B/F/TAF arm and completed the B/F/TAF-elderly study. Participant should be on B/F/TAF until day 1 of entry into the current study 4. HIV-1 RNA viral load < 50 copies/ml at screening (within 28 days prior to enrollment)
Exclusion criteria
Exclusion criteria: 1. Confirmed treatment failure as defined by two consecutive HIV-1 RNA viral loads = 50 copies/ml separated by at least 2 weeks, after at least 6 months on ART or after a documented HIV-1 RNA viral load < 50 copies/ml 2. Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative 3. Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV DNA 4. Has AST and/or ALT at least 5-times greater than the upper limit of normal 5. Severe hepatic impairment (Class C) as determined by Child-Pugh classification 6. Has a CrCl below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate) 7. Documented opportunistic infection within 4 weeks prior to the study enrolment 8. Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the study 9. Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible. 10. History or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. 11. Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia. 12. Participants who in the investigator’s judgment, poses a significant suicidality risk 13. Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants with plasma HIV-1 RNA = 50 copies/mL (Snapshot algorithm) at Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of disease progression (HIV associated conditions, AIDS, and death) through Weeks 24, 48 and 96.;Change in lipid parameters (total cholesterol, HDL and LDL cholesterol, triglyceride and TC/HDL ratio) from baseline to weeks 24, 48 and 96;Change in fasting blood sugar from baseline to weeks 48 and 96;Change in blood pressure over 24, 48 and 96 weeks;Mean change in weight at week 24, 48 and 96;Change from baseline in total and regional (trunk and limbs) fat and lean (fat-free) mass by DXA at 96 weeks in a subset of participants performing DXA scans;Proportion of participants with = 10% weight gain at weeks 48 and 96;Change from baseline in ASCVD score at weeks 48 and 96;Patient satisfaction (HIVTSQs) at baseline, weeks 24 and 96;Patient satisfaction (HIVTSQc) at week 48;To evaluate health related quality of life (WHOQOL HIV) at baseline, week 48 and week 96;To assess the occurrence of viral resistance in participants meeting confirmed virologic withdrawal criterion (Plasma HIV-1 RNA = 200 copies/mL preceded by a Plasma HIV-1 RNA = 50 copies/mL) over time;To investigate the incidence and severity of AEs and laboratory abnormalities over time through Week 96;To investigate the occurrence of DTG/3TC-non-Serious Adverse drug-related reactions, all SAEs and proportion of participants who discontinue treatment due to adverse event;To assess the change from Baseline (Day 1) in renal biomarkers at Weeks 48 and 96;To assess changes from baseline in estimated glomerular filtration rate (Creatinine and Cystatin-C, CKD-EPI, and urinary protein/creatinine at 48 and 96 weeks;To assess the change from baseline in AST, ALT and GGT levels at week 48 and 96;Participants with plasma HIV-1 RNA = 50 copies/mL (Snapshot algorithm) at 24 and 96 weeks;Participants with plasma HIV-1 RNA <50 copies/mL (Snapshot algorithm) at 24, 48 and 96 weeks;Absolute values and changes from baseline in CD4+ cells count and CD4:CD8 ratio at 24, 48 and 96 weeks | — |
Countries
Kenya
Contacts
Public ContactJoseph Nkuranga
Study Coordinator
Outcome results
None listed