REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCAN Community Health
About this trial
Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.
The REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B/F/TAF on the same day that they return to care. B/F/TAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.
Researchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age at the time of signing the informed consent form (ICF)
Diagnosis of HIV-1 confirmed by any positive HIV 4th generation test or detectable HIV-1 RNA level in >6 months
Previously received ART for ≥30 consecutive days, as self-reported
No ART dose received for ≥12 weeks prior to provision of informed consent, by any route of administration (i.e., injection or oral), as self-reported
Disqualifiers
Diagnosis of HIV-2 infection
Known or suspected history of severe hepatic impairment (Child-Pugh Class C)
Known or suspected history of severe renal impairment (estimated creatinine clearance [eCrCl] <30 mL/min)
Concomitant medication that is contraindicated with B/F/TAF
Trial design
Design model
Single group
Treatments tested in this trial
Bictegravir, emtricitabine, and tenofovir alafenamide
DrugOral, film-coated tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF taken once daily with or without food administered for 24 or 48 weeks.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Open-label B/F/TAFExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants in Cohort 1 with plasma HIV-1 RNA <50 copies/mL
Percentage of all participants who have plasma HIV-1 RNA Viral Load \<50 c/mL at W24 using FDA snapshot analysis, which defines a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation
Time frame
Week 242
Percentage of participants in Cohort 2 with plasma HIV-1 RNA ≥50 copies/mL
Percentage of all participants who have plasma HIV-1 RNA Viral Load ≥50 c/mL at W24 using FDA snapshot analysis, which defines a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation
Time frame
Week 24Secondary outcomes
1
Percentage of participants with plasma HIV-1 RNA <50 copies/mL
Percentage of participants with HIV-1 RNA \<50 copies/mL assessed at Weeks 12, 24, and 48, using FDA snapshot analysis and missing values excluded
Time frame
48 weeks2
Percentage of participants with plasma HIV-1 RNA <200 copies/mL
Percentage of participants with HIV-1 RNA \<200 copies/mL assessed at Weeks 12, 24, and 48, using FDA snapshot analysis and missing values excluded
Time frame
48 weeks3
Percentage of participants meeting protocol-defined virologic failure (PDVF) criteria in Cohort 1
Percentage of participants meeting PDVF criteria through Weeks 24 and 48. For Cohort 1, PDVF will be defined as Suboptimal Virologic Response, in which HIV-1 RNA ≥50 copies/mL and less than 1 log10 HIV-1 RNA reduction from Day 1 at the W12 visit, or Virologic Rebound, in which at any timepoint after achieving HIV-1 RNA \<50 copies/mL, a subsequent HIV-1 RNA measurement is noted to be ≥50 copies/mL, which is then confirmed at the following scheduled or unscheduled visit
Time frame
48 weeks4
Percentage of participants meeting PDVF criteria in Cohort 2
Percentage of participants meeting PDVF criteria through Weeks 24 and 48. For Cohort 2, PDVF will be defined as Confirmed Virologic Rebound, in which at any visit after Day 1, a rebound in HIV-1 RNA to ≥50 copies/mL, which is subsequently confirmed at the following scheduled or unscheduled visit, or any participant with HIV-1 RNA ≥50 copies/mL at the last on-treatment study visit (including E/D, lost to follow-up, or study endpoints)
Time frame
24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
CAN Community Health
Lead sponsor
Gilead Sciences
Collaborator
Midway Specialty Care Center
Collaborator
Costello Medical Inc.
Collaborator
Source ClinicalTrials.gov