Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

BACKGROUND: Three drug regimens for the treatment of HIV are widely used and successful in achieving viral suppression. However, they are associated with various adverse events including renal and bone disease, anaemia, mitochondrial toxicity, and possible association with increased cardiovascular events. Data from the ongoing B/F/TAF Elderly Switch Study has demonstrated high rates of renal insufficiency and osteoporosis in people living with HIV aged 60 years or more, hence the need for safe treatment options. Two drug regimens (2DR) have demonstrated non-inferiority to three drug regimens in patients who are treatment-naïve as well as in those who are virally suppressed on a first-line regimen and potentially have lower toxicity, fewer adverse drug events and a lower drug burden. OVERALL STRATEGY: This is a phase 3b, multi-centre, open-label, single-arm clinical trial over 96 weeks describing the efficacy of switching virally suppressed HIV-1 infected adults to DTG/3TC dual therapy from their current B/F/TAF regimen. The primary efficacy endpoint is the proportion of participants with viral load (VL) ≥ 50 copies/ml at week 48. The study will take place at two sites in Kenya: Kenyatta National Hospital (KNH, the largest teaching and referral hospital in Kenya), and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH, the largest teaching and referral hospital in the Nyanza region of Kenya). The outpatient HIV clinics at these sites currently provide antiretroviral therapy (ART) to over 15,000 persons living with HIV (PWH) combined. These two sites are currently participating in the B/F/TAF-elderly study. Study visits will take place at screening, baseline, and weeks 4, 12, 24, 36, 48, and 96 (with a 6-week extension as required for confirming HIV-1 RNA levels within the FDA snapshot window). HIV-1 RNA viral load will be performed at screening and weeks 4, 12, 24, 48 and 96. If HIV-1 RNA is ≥ 50 copies/ml then a repeat test will be performed at least 2 weeks after the detectable result to confirm virological failure. If the repeat HIV-1 RNA result is ≥ 50 copies/ml this confirms protocol-defined virological failure (PDVF) and genotypic resistance testing will be performed for any repeat viral load ≥ 500 copies/ml. Other routine study investigations will include CD4 count, complete blood count, serum Cr, renal biomarkers, alanine transaminase (ALT), aspartate aminotransferase (AST), fasting lipids, fasting glucose and patient satisfaction questionnaires (HIVTSQ). METHODS: The anticipated sample size is 240 participants started on study treatment among patients on B/F/TAF therapy for at least 24 weeks and no prior virological failure (defined as two consecutive HIV-1 RNA viral loads ≥ 50 copies/ml separated by at least 2 weeks), with a viral load of < 50 copies/ml for at least 12 weeks, and aged 60 years or above. All participants will be recruited from the pool of patients who are exiting the B/F/TAF-elderly trial at the two study sites. Those who provide written informed consent will be assessed for eligibility through review of their medical records, history and physical examination. Patients who provide informed consent and meet all eligibility criteria after screening investigations will be enrolled in the study within 28 days of the screening investigations and will complete baseline investigations (CD4 count, fasting lipid profile and fasting glucose). During the enrollment visit participants will be switched to DTG/3TC two drug regimen. Participants will be engaged in the study for 96 weeks plus up to 28 days between screening and enrolment, and a follow-up visit up to 28 days beyond the week 96 visit if required to confirm HIV-1 RNA within the FDA snapshot window. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06444620
Study type Interventional
Source University of Nairobi
Contact Joseph Nkuranga, MBChB, MSc
Phone +254 737 223988
Email dnkuranga@uonbi.ac.ke
Status Not yet recruiting
Phase Phase 3
Start date June 15, 2024
Completion date June 15, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT03940521 - Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Completed NCT03227731 - Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women Phase 2/Phase 3
Completed NCT03570918 - MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy Phase 1
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Active, not recruiting NCT04022967 - ANRS 12372 MODERATO Study Phase 3
Not yet recruiting NCT06337032 - A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments Phase 4
Not yet recruiting NCT06282783 - Studying Topiramate for Re-Activating the HIV-1 Reservoir Phase 1/Phase 2
Completed NCT04711265 - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Recruiting NCT03536234 - Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients Phase 2
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Withdrawn NCT05769569 - Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission Phase 1
Enrolling by invitation NCT05584397 - Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
Completed NCT04388904 - Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART) Phase 4
Not yet recruiting NCT04894357 - Impact of V106I on Resistance to Doravirine
Completed NCT04963712 - Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder Early Phase 1
Not yet recruiting NCT04311944 - Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD N/A
Not yet recruiting NCT04311957 - Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults Phase 4
Completed NCT04568239 - Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
Not yet recruiting NCT04513496 - Telemedicine in HIV Care in Buenos Aires
Completed NCT03998176 - Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE Phase 4