Status:
COMPLETED
BFTAF Elderly Switch Study
Lead Sponsor:
University of Nairobi
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV-1-infection
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
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)...
Detailed Description
BACKGROUND Kenya has the fourth largest burden of HIV globally with close to 1.5 million people living with HIV, with the highest prevalence seen in the age group 45-54 years. As PLHIV live longer wi...
Eligibility Criteria
Inclusion
- Able and willing to understand and comply with the protocol requirements, instructions and restrictions
- Able and willing to give informed consent
- Age 60 years or above
- Documented HIV-1 infection as confirmed by HIV-antibody testing as per the Kenya National Guidelines
- Has been receiving an ARV regimen for at least 24 weeks
- 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
- HIV-1 RNA viral load \< 50 copies/ml at screening (within 28 days prior to enrollment)
Exclusion
- 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
- Documented HIV-2 infection
- Using any concomitant therapy disallowed as per the reference safety information and product labeling for the study drugs
- Has AST and/or ALT at least 5-times greater than the upper limit of normal
- Has a creatinine clearance (CrCl) below 50 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)
- Documented opportunistic infection within 4 weeks prior to the study enrolment
- 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 azathioprine (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)
- 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
- History or presence of allergy to the study drugs or their components
- BMD monitoring population will also exclude any participant 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)
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT05243602
Start Date
February 1 2022
End Date
March 18 2024
Last Update
May 8 2024
Active Locations (2)
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1
Jaramogi Oginga Odinga Teaching and Referral Hospital
Kisumu, Kenya
2
Kenyatta National Hospital
Nairobi, Kenya