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BFTAF Elderly Switch Study

NCT05243602 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Switch to B/F/TAF

This is a combined pill containing 50mg of bictegravir, 200mg of emtricitabine and 25mg of tenofovir alafenamide

DRUG

Continue current regimen

Participants will continue taking the same ARV regimen they were on before enrollment with no change in drug or dosage for the duration of the trial

Sponsors & Collaborators

Principal Investigators

  • Loice Achieng Ombajo, MD, MSc · University of Nairobi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-04-11
Completion
2024-03-18

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243602 on ClinicalTrials.gov