HIV/AIDS
Conditions
Interventions
Switch to BFTAF
Continue with current ARV Regimen
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. Age 60 years or above 4. Documented HIV-1 infection as confirmed by HIV-antibody testing as per the Kenya National Guidelines 5. Has been receiving an ARV regimen for at least 24 weeks 6. Documented HIV-1 RNA viral load < 50 copies/ml at least 12 weeks prior to enrollment and no viral rebound between the first viral load < 50 copies/ml and the screening viral load 7. 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. Documented HIV-2 infection 3. Using any concomitant therapy disallowed as per the reference safety information and product labeling for the study drugs 4. Has AST and/or ALT at least 5-times greater than the upper limit of normal 5. Has a CrCl below 50 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate) 6. Documented opportunistic infection within 4 weeks prior to the study enrolment 7. Investigator opinion that the patient should switch or discontinue any ARV in their current regimen immediately for clinical reasons (e.g. anemia with Hb < 9.5 g/dl while currently on AZT; HBsAg positive without currently being on TDF or TAF plus 3TC or FTC; experiencing adverse events associated with any ARV in current regimen deemed significant enough to warrant immediate change in regimen) 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. History or presence of allergy to the study drugs or their components 10. BMD monitoring population will also exclude any subject with a pre-existing condition which is likely to decrease validity of bone mineral density estimations (including pre-existing vertebral or bilateral hip fractures, lytic or blastic metastases, bilateral hip arthroplasty, or lumbar spine internal fixation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the non-inferiority of switching to B/F/TAF, compared to maintaining the current ARV regimen, in virologically suppressed HIV-1 positive elderly adults (= 60 years) with no prior confirmed virological failure, as determined by HIV-1 RNA PCR = 50 copies/ml at week 48;To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in lumbar spine bone mineral density (BMD) after 48 weeks as measured by dual-energy x-ray absorptiometry (DXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the impact of switching to B/F/TAF on development of virological failure at week 24 and 96;To assess the impact of switching to B/F/TAF on maintenance of virological suppression at weeks 24, 48 and 96;To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in lumbar spine BMD at week 24 and 96;To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in total hip BMD at weeks 24, 48 and 96;To evaluate the impact of switching to B/F/TAF on Fracture Risk Assessment Tool (FRAX) score at weeks 24, 48 and 96;To evaluate the impact of switching to B/F/TAF on patient satisfaction as measured by the HIV Treatment Satisfaction Questionnaire (HIVTSQ) at weeks 24, 48 and 96;To assess the impact of switching to B/F/TAF on change in CD4 count at weeks 24, 48 and 96;To assess the impact of switching to B/F/TAF on renal function at weeks 24, 48 and 96;To assess the impact of switching to B/F/TAF on change in total cholesterol at weeks 24 and 48;To assess the impact of switching to B/F/TAF on change in low-density lipoprotein at weeks 24 and 48;To assess the impact of switching to B/F/TAF on change in triglycerides at weeks 24 and 48;To assess the impact of switching to B/F/TAF on change in total cholesterol to HDL ratio at weeks 24 and 48;To assess the impact of switching to B/F/TAF on change in fasting blood glucose at weeks 24 and 48;To evaluate the impact of switching to B/F/TAF on safety and tolerability (laboratory and clinical adverse events) at weeks 24 and 48;To investigate the impact of switching to B/F/TAF on change in weight at weeks 24 and 48;To investigate the impact of switching to B/F/TAF on change in body-mass index at weeks 24 and 48;To investigate the impact of switching to B/F/TAF on change in waist-hip ratio at weeks 24 and 48;To investigate the impact of switching to B/F/TAF on change in waist circumference at weeks 24 and 48;To describe the genotypic resistan | — |
Countries
Kenya
Contacts
Public ContactJoseph Nkuranga
Trial Coordinator
Outcome results
None listed