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ACTIVE NOT RECRUITING
NCT06444620
PHASE3

B/F/TAF to DTG/3TC Switch Study

Sponsor: University of Nairobi

View on ClinicalTrials.gov

Summary

OBJECTIVE: To assess the efficacy and safety of switch to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in persons living with HIV aged 60 years old or more. METHODS: This is a phase 3b, multi-center, open-label, single-arm clinical trial over 96 weeks. The study will take place at two sites in Kenya: Kenyatta National Hospital (KNH) and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Study visits will take place at screening, baseline, and weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96 (with a 6-week extension as required for confirming HIV-1 RNA levels). A target of 240 participants from the ongoing B/F/TAF Elderly Switch Study will be enrolled. Eligible participants will be switched from B/F/TAF to DTG/3TC at enrollment and followed up for 96 weeks. The primary endpoint will be the proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at Week 48. Analysis of the primary endpoint will be performed for the intention to treat - exposed (ITT-E) population using the FDA snapshot method.

Official title: Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen From B/F/TAF in Older Persons Living With HIV in Kenya

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-07-22

Completion Date

2026-12-22

Last Updated

2025-09-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

DTG/3TC

This is a fixed-dose combined DTG/3TC pill each containing 50mg of dolutegravir and 300mg of lamivudine

Locations (2)

Jaramogi Oginga Odinga Teaching and Referral Hospital

Kisumu, Kenya

Kenyatta National Hospital

Nairobi, Kenya