NCT05243602 (BFTAF) is a Phase 4 clinical trial of Switch to B/F/TAF in HIV-1-infection, sponsored by University of Nairobi.

Who is sponsoring NCT05243602?

NCT05243602 is sponsored by University of Nairobi.

What drugs are being tested in NCT05243602?

Interventions in NCT05243602: Switch to B/F/TAF, Continue current regimen.

What condition does NCT05243602 study?

NCT05243602 studies HIV-1-infection.

Is NCT05243602 still recruiting?

NCT05243602 is currently completed. Last updated 8 May 2024.

Last reviewed 2024-05-08 · How we verify

NCT05243602: BFTAF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BFTAF Elderly Switch Study

Completed Phase 4 Last updated 8 May 2024

What this trial tests

Phase 4 trial testing Switch to B/F/TAF in HIV-1-infection in 520 participants. Completed in 18 March 2024.

Timeline

1 February 2022

Primary endpoint
11 April 2023

18 March 2024

Quick facts

Lead sponsor	University of Nairobi
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	520
Start date	1 February 2022
Primary completion	11 April 2023
Estimated completion	18 March 2024
Sites	2 locations across Kenya

Drugs / interventions tested

Switch to B/F/TAF — full drug profile →
Continue current regimen — full drug profile →

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

University of Nairobi

Who can join

60 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

High rates of kidney impairment among older people (≥ 60 years) living with HIV on first-line antiretroviral therapy at screening for a clinical trial in Kenya.
Penner J, Ombajo LA, Otieno D, Nkuranga J, et al · · 2023 · cited 7× · PMID 37352206 · DOI 10.1371/journal.pone.0285787
First-Line Switch to B/F/TAF for Treatment of HIV in Older Adults ≥60 Years in Kenya (the B/F/TAF-Elderly Study).
Ombajo LA, Penner J, Nkuranga J, Omodi V, et al · · 2025 · PMID 41280315 · DOI 10.1093/ofid/ofaf653

Verify or expand the search:

Other recruiting trials for HIV-1-infection

Currently open trials in the same condition.

NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States · recruiting
NCT06919016 — A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1- · Phase 1 · active not recruiting
NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV · Phase 2 · recruiting
NCT06774872 — Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Succes · Phase 2 · recruiting
NCT06890988 — Ending the Epidemic Interventions in the Dental Setting - UH3 · NA · recruiting

Other University of Nairobi trials

Trials by the same sponsor.

NCT06444620 — B/F/TAF to DTG/3TC Switch Study · Phase 3 · active not recruiting
NCT04229290 — Second-line Switch to Dolutegravir Study · Phase 4 · completed
NCT04013724 — Efficacy of Group Tobacco Cessation Interventions Among Tobacco Users With Mental Illness: Controlled Clinical Trial · NA · completed
NCT04879472 — Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05243602 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Nairobi
Last refreshed: 8 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05243602.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing