BFTAF Elderly Switch Study

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

BACKGROUND: Current Kenya National Anti-retroviral (ARV) Guidelines and World Health Organization (WHO) Guidelines recommend first-line therapy of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and dolutegravir (DTG) for adult people living with HIV (PLHIV). This regimen has limitations, particularly for the aging PLHIV who are more likely to have pre-existing comorbidities and higher risk of developing comorbidities, including osteopenia, osteoporosis, and renal insufficiency. Abacavir, the preferred alternative nucleoside reverse transcriptase inhibitor (NRTI) in Kenya, is associated with increased cardiovascular risk that also limits its use in elderly populations. B/F/TAF is highly efficacious, well tolerated, co-formulated in a small pill, and does not have the same bone, renal or cardiovascular risks associated with currently recommended regimens in Kenya. We are not aware of any clinical trial to date that has been fully powered to compare ARV regimens for the increasing population of elderly PLHIV.

BROAD OBJECTIVE: We will compare the efficacy, safety, and impact on bone mineral density of switching to B/F/TAF to that of remaining on current ARV regimen in a population of elderly patients (60 years old or greater) with no prior confirmed treatment failure in Kenya.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nairobi
• Collaborator: Gilead Sciences

Criteria

Inclusion Criteria:

• Able and willing to understand and comply with the protocol requirements, instructions and restrictions

• Able and willing to give informed consent

• Age 60 years or above

• Documented HIV-1 infection as confirmed by HIV-antibody testing as per the Kenya National Guidelines

• Has been receiving an ARV regimen for at least 24 weeks

• 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

• HIV-1 RNA viral load < 50 copies/ml at screening (within 28 days prior to enrollment)

Exclusion Criteria:

• 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

• Documented HIV-2 infection

• Using any concomitant therapy disallowed as per the reference safety information and product labeling for the study drugs

• Has AST and/or ALT at least 5-times greater than the upper limit of normal

• Has a creatinine clearance (CrCl) below 50 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)

• Documented opportunistic infection within 4 weeks prior to the study enrolment

• 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 azathioprine (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)

• 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

• History or presence of allergy to the study drugs or their components

• BMD monitoring population will also exclude any participant 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)