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

Phase 3

Not yet recruiting

• Conditions: HIV/AIDS

• Registration Number: PACTR202404870570433
• Lead Sponsor: niversity of Nairobi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-25
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

1. 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
2. Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative
3. 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
4. Has AST and/or ALT at least 5-times greater than the upper limit of normal
5. Severe hepatic impairment (Class C) as determined by Child-Pugh classification
6. Has a CrCl below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)
7. Documented opportunistic infection within 4 weeks prior to the study enrolment
8. 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
9. 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.
10. 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.
11. 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.
12. Participants who in the investigator’s judgment, poses a significant suicidality risk
13.Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation

Study & Design

• Study Type: Interventional
• Study Design: Not specified