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

NCT06444620 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: Sungura Study
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV-1-infection

Keywords

HIV; Bictegravir; Tenofovir alafenamide; Dolutegravir; Dual therapy; First-line; Elderly; Switch

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with virological failure at week 48

  Number and proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL as per the FDA Snapshot algorithm) at Week 48

  48 weeks

Secondary Outcomes (25)

• Proportion of participants with virological failure at week 24

  24 weeks

• Proportion of participants with virological failure at week 96

  96 weeks

• Proportion of participants with treatment success

  24, 48 and 96 weeks

• Change in CD4

  24, 48 and 96 weeks

• Number of participants with HIV disease progression

  24, 48 and 96 weeks

Study Arms (1)

Switch to DTG/3TC 2DR

EXPERIMENTAL

Participants will be switched from B/F/TAF to a fixed-dose combined DTG/3TC pill each containing 50mg of dolutegravir and 300mg of lamivudine taken once daily for the duration of the study

Drug: DTG/3TC

Interventions

DTG/3TC DRUG

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

Also known as: Avridela

Switch to DTG/3TC 2DR

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to understand and comply with the protocol requirements, instructions and restrictions
• Able and willing to give informed consent
• Have been randomised to the B/F/TAF arm and completed the B/F/TAF-elderly study. Participants should be on B/F/TAF until day 1 of entry into the current study
• HIV-1 RNA viral load \< 50 copies/ml at screening (within 28 days prior to enrollment)

You may not qualify if:

• 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
• Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative (see Section 5.2. under Prohibited medications and non-drug therapies)
• Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
• Participants positive for HBsAg are excluded;
• Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded;
• Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
• Has AST and/or ALT at least 5-times greater than the upper limit of normal
• Severe hepatic impairment (Class C) as determined by Child-Pugh classification
• Has an estimated creatinine clearance (CrCl) below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)
• Documented opportunistic infection within 4 weeks prior to the study enrolment
• 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
• Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.
• History or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
• Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk

Sponsors & Collaborators

• University of Nairobi: lead
• ViiV Healthcare: collaborator

Study Sites (2)

Jaramogi Oginga Odinga Teaching and Referral Hospital

Kisumu, Kenya

Location

Kenyatta National Hospital

Nairobi, Kenya

Location

Study Officials

• Loice A Ombajo, MD, MSc

  University of Nairobi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 5, 2024
• Study Start: July 22, 2024
• Primary Completion: August 21, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the final manuscript and for a period of 36 months
• Access Criteria: Access to IPD will be subject to the University of Nairobi data sharing requirements. Written requests should be submitted to the Principal Investigator providing a brief description of the individual or group making the request and detailing the reason for the same. Prior to sharing the data, the requestor will be required to sign a data access and sharing agreement.

Locations

KE (2)