None listed
Conditions
Brief summary
The primary objective of this study is to examine the tolerability and antiviral activity of switching to Biktarvy from a current antiretroviral regimen (CAR) consisting of a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) and /or a Protease Inhibitor (PI) in HIV-1 infected antiretroviral therapy (ART) experienced subjects aged 55 years and older who are virologically suppressed as determined by the proportion of subjects with HIV-1 RNA greater than or equal to 50copies/mL at Week 48. The primary outcome of interest change in viral load from baseline to Week 48 will be formally tested under the assumption that “higher is bad”. Similarly change in CD4 t cell count from baseline to week 48 will also be formally tested under the assumption that “higher is good”. The secondary objective is to evaluate quality of life and safety of the treatment group through Week 48. The secondary outcome of interest change in distress index assessments from baseline to Week 48 will be formally tested under the assumption that” no difference between the two time points”
Interventions
This is a 55 years and older cohort of a switch, open-labelled study to Biktarvy from current antiretroviral regimen with analysis of changes in viral load, CD4+ cell count and patient reported outcomes at week 48 compared to those at baseline.
Biktarvy is a fixed dose combination (FDC) tablet containing three medications: Bictegravir 50mg (BIC), Tenofovir Alafenamide 25mg (TAF) and Emtricitabine 200mg (FTC).
Participants who are 55 years and older will receive Biktarvy tablets administered
This is a 55 years and older cohort of a switch, open-labelled study to Biktarvy from current antiretroviral regimen with analysis of changes in viral load, CD4+ cell count and patient reported outcomes at week 48 compared to those at baseline. Biktarvy is a fixed dose combination (FDC) tablet containing three medications: Bictegravir 50mg (BIC), Tenofovir Alafenamide 25mg (TAF) and Emtricitabine 200mg (FTC). Participants who are 55 years and older will receive Biktarvy tablets administered orally, once daily without regard to food. The treatment period of this study is at least 48 weeks (approximately 11 months), not including the screening period which may last up to 30 days. Subjects will be instructed to bring all study medication in the original container at each clinic visit for drug accountability. The Investigator or study coordinator will be responsible for maintaining accurate records for all study drug bottles dispensed and tablets returned. The inventory and dispensing logs must be available for study drug accountability
Sponsors
Taylor Square Private Clinic
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. 2. Age 55 years and older. 3. Currently receiving an antiretroviral regimen which can consist of a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) and /or a Protease Inhibitor (PI) greater than or equal to 6 months preceding the screening visit. 4. HIV RNA less than 50 copies/mL at the screening visit. 5. Females of childbearing potential must agree to utilize protocol recommended highly effective contraceptive methods or be non-heterosexually active or practice sexual abstinence (as defined in Appendix 1) from screening, throughout the duration of the study period. a) Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study drug dosing. 6. Male subjects who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception (as described in Appendix 1) throughout the study period. 7. Male subjects must agree to refrain from sperm donation from first study drug dose until at least 90 days following the last study drug dose. 8. Currently on a stable regimen greater than or equal to 6 months preceding the Screening visit with documented plasma HIV-1 RNA less than 50 copies/mL for 6 months preceding the Screening visit 9. Have no documented or suspected resistance to TAF and FTC.
Exclusion criteria
1. Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies). 2. Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance. 3. A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study. 4. Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1. 5. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements. 6. Any known allergies to the excipients of BIC/TAF/FTC. 7. Females who are pregnant (as confirmed by positive serum pregnancy test). 8. Females who are breastfeeding. 9. Administration of any Prohibited Medication eg. Dofetilide, Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine and St. John’s Wort must be discontinues at least 30 days prior to the Day 1 Visit and the duration of the study. 10. Severe hepatic impairment and unstable liver disease.
Outcome results
None listed