BFTAF Elderly Switch Study

Phase 4

• Conditions: HIV/AIDS

• Registration Number: PACTR202104807460491
• Lead Sponsor: niversity of Nairobi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 516

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. Age 60 years or above
4. Documented HIV-1 infection as confirmed by HIV-antibody testing as per the Kenya National Guidelines
5. Has been receiving an ARV regimen for at least 24 weeks
6. Documented HIV-1 RNA viral load < 50 copies/ml at least 12 weeks prior to enrollment and no viral rebound between the first viral load < 50 copies/ml and the screening viral load
7. 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. Documented HIV-2 infection
3. Using any concomitant therapy disallowed as per the reference safety information and product labeling for the study drugs
4. Has AST and/or ALT at least 5-times greater than the upper limit of normal
5. Has a CrCl below 50 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)
6. Documented opportunistic infection within 4 weeks prior to the study enrolment
7. Investigator opinion that the patient should switch or discontinue any ARV in their current regimen immediately for clinical reasons (e.g. anemia with Hb < 9.5 g/dl while currently on AZT; HBsAg positive without currently being on TDF or TAF plus 3TC or FTC; experiencing adverse events associated with any ARV in current regimen deemed significant enough to warrant immediate change in regimen)
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. History or presence of allergy to the study drugs or their components
10. BMD monitoring population will also exclude any subject with a pre-existing condition which is likely to decrease validity of bone mineral density estimations (including pre-existing vertebral or bilateral hip fractures, lytic or blastic metastases, bilateral hip arthroplasty, or lumbar spine internal fixation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified