HIV -1 InfectionPhase 4REINITIATENCT07476339
REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE
A Phase 4 study testing Bictegravir, emtricitabine, and tenofovir alafenamide in people with HIV -1 Infection and HIV (Human Immunodeficiency Virus), run by CAN Community Health at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV -1 Infection, HIV (Human Immunodeficiency Virus), HIV
- What is being tested?
- Bictegravir, emtricitabine, and tenofovir alafenamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Jun 2026to 17 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
- Returning to care with an interest to restart ART therapy
- Body weight ≥55.12lbs (25 kg)
- Signed ICF as described in the protocol which includes compliance with the requirements and restrictions listed in ICF and study protocol
Who cannot join
- 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
- Known or suspected resistance to BIC (resistance-associated mutations [RAMs] include: G118R, Y143C/H/R, Q148H/K/R, N155H/S, or R263K in the integrase gene)
- Known/suspected resistance to tenofovir (TFV) (RAMs include: K65R/E/N, or K70E)
Show all 10Show fewer
- Known/suspected history of 3 or more thymidine analog mutation (TAMs) (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in reverse transcriptase (RT)
- History of B/F/TAF intolerance
- Unable to swallow whole tablets or swallow tablets cut into halves
- Unable to communicate in either English or Spanish
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
CAN Community Health
Clearwater, Florida, 33765
Jessica Altamirano, MD, 786-800-5631, jaltamirano@cancommunityhealth.org
Jeanette Cancel, MD, 727-216-6193, jcancel@cancommunityhealth.org
- Recruiting
Midway Specialty Care Center
Ft. Pierce, Florida, 34982
Hector Bolivar, MD, 561-249-2279, drbolivar@midwaycare.org
Jenn L Kuretski, DNP, APRN, NP-C,AAHIVS, 772-464-9746, Jkuretski@midwaycare.org
- Recruiting
CAN Community Health
Jacksonville, Florida, 32207
Jessica Altamirano, MD, 786-800-5631, jaltamirano@cancommunityhealth.org
Katherine Rogers, APRN, 904-508-0701, krogers@cancommunityhealth.org
- Recruiting
CAN Community Health
Las Vegas, Nevada, 89104
Jessica Altamirano, MD, 786-800-5631, jaltamirano@cancommunityhealth.org
Archer Grimley, MD, 702-979-1111, archgrimley@cancommunityhealth.org
- Recruiting
CAN Community Health
Orlando, Florida, 32804
Jessica Altamirano, MD, 786-800-5631, jaltamirano@cancommunityhealth.org
Vincenzo Scotto D'Antuono, MD, 407-246-1946, vsdantuono@cancommunityhealth.org
- Recruiting
Midway Specialty Care Center
Orlando, Florida, 32819
Hector Bolivar, MD, 561-249-2279, drbolivar@midwaycare.org
Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS, 407-745-1171, Jkuretski@midwaycare.org
- Recruiting
CAN Community Health
Tampa, Florida, 33602
Jessica Altamirano, MD, 786-800-5631, jaltamirano@cancommunityhealth.org
Elier Rodriguez, MD, 941-300-4440, erodriguez@cancommunityhealth.org
- Recruiting
Midway Specialty Care Center
Temple Terrace, Florida, 33617
Hector Bolivar, MD, 561-249-2279, drbolivar@midwaycare.org
Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS, 813-733-8224, Jkuretski@midwaycare.org
- Recruiting
Midway Specialty Care Center
West Palm Beach, Florida, 33409
Hector Bolivar, MD, 561-249-2279, drbolivar@midwaycare.org
Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS, 561-249-2279, Jkuretski@midwaycare.org
- Recruiting
Midway Specialty Care Center
Wilton Manors, Florida, 33334
Hector Bolivar, MD, 561-249-2279, drbolivar@midwaycare.org
Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS, 954-530-8357, Jkuretski@midwaycare.org
About this study
Official title: A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks
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.
Read the detailed description
This prospective, multicenter, open-label, single-arm, Phase 4, interventional study aims to evaluate rapid antiretroviral therapy (ART) restart with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in participants' routine clinical environments, facilitating data collection on treatment effectiveness and safety following same-day ART reinitiation amongst treatment-experienced people with HIV (PWH) who have had a treatment interruption of at least 12 weeks. This study will also characterize reasons for ART interruption and reinitiation.
B/F/TAF, a three-drug combination of bictegravir (B; a second-generation HIV-1 integrase strand transfer inhibitor [INSTI]), and emtricitabine (F) and tenofovir alafenamide (TAF), both nucleoside reverse transcriptase inhibitors (NRTIs), is a recommended initial ART regimen for most people with HIV in the United States. B/F/TAF is an oral, once-daily fixed-dose combination (FDC) that provides a potent and well-tolerated regimen for the treatment of HIV-1 infection in people, including those with some pre-existing resistance and subpopulations that are underrepresented in clinical trials, including Black, Hispanic, and Latine PWH, PWH ≥65 years old, and pregnant adults.
The rapid restart nature of this study involves the concurrent initiation of screening, baseline assessments, and administration of B/F/TAF on the same day. B/F/TAF is the only guideline-recommended single tablet regimen (STR) suitable for rapid restart, as it can be prescribed without prior knowledge of baseline laboratory parameters, including viral load, hepatitis B virus (HBV) status, or baseline genotypic resistance testing. This means the study treatment commences without baseline test results, provided the participant fulfills all eligibility criteria.
There will be two Cohorts of participants within this study: Cohort 1 will include viremic participants (defined by HIV-1 RNA ≥50 copies/mL) at baseline and Cohort 2 will include virologically suppressed participants (defined by HIV-1 RNA <50 copies/mL) at baseline. The study will aim to recruit 125 participants into Cohort 1 while simultaneously recruiting into Cohort 2 (it is assumed approx. 15-75 participants). The ratio of participants in Cohort 1 and Cohort 2 will be monitored during enrollment. Adherence and drop-out rates will be closely monitored throughout the study to mitigate the risk of insufficient sample sizes to power the planned analyses. Each participant's total study participation duration will be up to 48 weeks for data collection. Participants will be followed prospectively for 48 weeks in Cohort 1 and for 24 weeks in Cohort 2. Optional, semi-structured interviews will be conducted for a subset of participants in Cohorts 1 and 2 via teleconference at week 4 and week 24 after baseline screening and treatment reinitiation. While sample size will be informed by theoretical saturation, ~30 participants (15 per Cohort) is estimated to be sufficient.
Achieving viral suppression (defined as HIV-1 RNA <50 copies/mL) is the main goal of ART therapy for PWH who are viremic, and the primary objective of this study. It has been associated with improvements in CD4 cell counts, prevention of HIV drug resistance, AIDS- and non-AIDS-related events, and decreased transmission to sexual partners of PWH. Secondary outcomes include safety, resistance, persistence and adherence, and a range of patient-reported outcomes to understand patient experiences of ART.
- Being tested
- Bictegravir, emtricitabine, and tenofovir alafenamide
- Keywords
- HIV-1, HIV Infections, Bictegravir, Emtricitabine, Tenofovir Alafenamide, Antiretroviral Therapy, Antiretroviral Therapy, Highly Active, Treatment Interruption, Virologically Suppressed, Treatment-Experienced, Returning to Care, Phase 4, B/F/TAF, B/F/TAF; bictegravir, emtricitabine, tenofovir alafenamide, drug combination, Rapid Restart
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bictegravir, emtricitabine, and tenofovir alafenamideDrug
Also called B/F/TAF, BIKTARVY®
Oral, 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.
| Study group | Role | What they receive |
|---|---|---|
| Open-label B/F/TAF | Experimental | All participants receive open-label B/F/TAF. Treatment duration is determined by baseline viral load: viremic participants (defined by HIV-1 RNA ≥50 copies/mL) at baseline will receive 48 weeks of B/F/TAF; virologically suppressed participants (defined by HIV-1 RNA <50 copies/mL) at baseline will receive 24 weeks of B/F/TAF. Receives: Drug: Bictegravir, emtricitabine, and tenofovir alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 24
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
Measured: Week 24
Secondary outcomes (22)
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
Measured: 48 weeks
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
Measured: 48 weeks
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
Measured: 48 weeks
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)
Measured: 24 weeks
Absolute and change from baseline in log10 HIV-1 RNA viral load of participants
Absolute and change from baseline in log10 HIV-1 RNA viral load at Weeks 12, 24, and 48
Measured: 48 weeks
Absolute and change from baseline CD4 T-cell count of participants
Absolute and change from baseline CD4 T-cell count at Weeks 12, 24, and 48. The CD4 T-cell count will be determined using the participant's blood sample. This test serves as a marker of immune system integrity and is used to evaluate immune suppression and disease progression, and monitor B/F/TAF efficacy
Measured: 48 weeks
Percentage of participants discontinuing due to adverse events (AEs) or intolerability
Percentage of patients discontinuing study treatment due to AEs or other intolerability through Weeks 24 and 48
Measured: 48 weeks
Percentage of participants experiencing treatment-emergent Grade 3-4 laboratory abnormalities
Incidence of new Grade 3-4 lab abnormalities through Weeks 24 and 48
Measured: 48 weeks
Percentage of participants experiencing treatment-emergent Grade 3-4 drug-related adverse events
Incidence of Grade 3-4 adverse events considered drug-related through Weeks 24 and 48
Measured: 48 weeks
Percentage of Participants experiencing Serious Adverse Events (SAEs)
Incidence of SAEs through Weeks 24 and 48. All SAEs will be collected from the date of the first dose of the study drug until the end of on-study treatment + 30 days
Measured: 48 weeks
Baseline resistance to B/F/TAF
Proportion of participants with pre-existing genotypic or phenotypic resistance to any component of B/F/TAF at study entry
Measured: 4 weeks
Treatment-emergent resistance in PDVF participants in Cohort 1
Proportion of participants with PDVF who develop treatment-emergent genotypic or phenotypic resistance to any component of B/F/TAF. 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
Measured: 48 weeks
Treatment-emergent resistance in PDVF participants in Cohort 2
Proportion of participants with PDVF who develop treatment-emergent genotypic or phenotypic resistance to any component of B/F/TAF. 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)
Measured: 24 weeks
Total satisfaction score on the HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs)
Total score at Weeks 4, 24, and 48 on the HIVTSQs on a scale of 0 (very dissatisfied) to 6 (very satisfied)
Measured: 48 weeks
Change from Week 4 on the Total HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) score
Change in total HIVTSQ satisfaction score from Week 4 to Weeks 24 and 48 on a scale of 0 (very dissatisfied) to 6 (very satisfied)
Measured: 48 weeks
Total and change from baseline in the symptom distress score on the HIV-Symptom Index (HIV-SI)
Total score and change from baseline at Weeks 4, 24, and 48 on the HIV-SI on a scale of 0 ("I do not have this symptom") to 4 ("It bothers me a lot")
Measured: 48 weeks
Health-related quality of life by EuroQol 5-Dimension 5-Level (EQ-5D-5L) total score and change from baseline
Total EQ-5D-5L score and change from baseline at Weeks 4, 24, and 48 with a scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
Measured: Week 4
Reasons for prior ART discontinuation and current reinitiation
Participant-reported reasons for previous ART discontinuation and for reinitiation at study entry
Measured: Baseline
Proportion of participants lost to follow-up
Participants with no study contact through Week 48
Measured: Week 48
Proportion of participants on study drug with documented clinic visit
Participants taking study drug at Week 48 who have a clinic visit within 90 days after their post-treatment safety follow-up visit (Week 48 + 30 days)
Measured: Week 48
Adherence to B/F/TAF by pill count or dried blood spot (DBS)
Adherence rate as measured by pill counts or DBS at scheduled and/or unscheduled visits through Week 48
Measured: Week 48
Participant experiences returning to care after HIV treatment interruption
Semi-structured qualitative interviews will be conducted at Weeks 4 and 24 to investigate the experience of PWH who are returning to care after interrupting treatment, including barriers to initial retention in care and reasons for disengagement, motivators for re-engagement with care, as well as barriers to this process, perceptions about future risk of disengagement with care following re-engagement, and impact of restarting treatment on first visit with B/F/TAF
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start17 Jun 2026
- Primary completion17 Jun 2027 (estimated)
- Study completion17 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, non-randomized study without a control group. The rapid restart nature of this study involves the concurrent initiation of screening, baseline assessments, and administration of B/F/TAF on the same day. The study treatment commences without all baseline test results being available, provided the participant fulfills all eligibility criteria. All eligible participants commence on the same oral, once-daily, fixed-dose combination of B/F/TAF which is a single-tablet regimen of 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). Once baseline assessment of viral load results are available participants are allocated into the relevant cohort which defines the duration of their study intervention. Cohort 1 (48 week follow up) will include viremic participants (HIV-1 RNA ≥50 copies/mL) at baseline and Cohort 2 (24 week follow up) will include virologically suppressed participants (HIV-1 RNA \<50 copies/mL) at baseline.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAN Community Health
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Midway Specialty Care Center, Costello Medical Inc.
- Responsible party
- Sponsor
- Investigators
- Jessica Altamirano, MD, Principal investigator, CAN Community HealthHector Bolivar, MD, Principal investigator, Midway Specialty Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476339
- Sponsor's protocol ID
- CAN-MID-REINITIATE-01
- Other IDs
- CO-US-380-7671, CO-US-380-7672
- Acronym
- REINITIATE
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be made available to other researchers. This decision is based on considerations related to the vulnerability of the study population and the need to uphold the highest standards of data protection and confidentiality. Given that participants are living with HIV-1, which is a condition associated with significant social, legal, and personal sensitivities, sharing IPD could increase the risk of inadvertent disclosure of sensitive personal information. Ensuring the privacy and protection of identities and health data of participants is essential; therefore, we have decided not to make IPD available for other researchers' use.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks
- ClinicalTrials.gov ID
- NCT07476339
- Acronym / sponsor ID
- REINITIATE / CAN-MID-REINITIATE-01
- Keywords
- HIV-1, HIV Infections, Bictegravir, Emtricitabine, Tenofovir Alafenamide, Antiretroviral Therapy, Antiretroviral Therapy, Highly Active, Treatment Interruption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CAN Community HealthUniversity, hospital or other
- Collaborators
- Gilead Sciences, Midway Specialty Care Center, Costello Medical Inc.
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 17 Jun 2027 (estimated)
- Study completion
- 17 Jun 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, multicenter, open-label, single-arm, Phase 4, interventional study aims to evaluate rapid antiretroviral therapy (ART) restart with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in participants' routine clinical environments, facilitating data collection on treatment effectiveness and safety following same-day ART reinitiation amongst treatment-experienced people with HIV (PWH) who have had a treatment interruption of at least 12 weeks. This study will also characterize reasons for ART interruption and reinitiation.
B/F/TAF, a three-drug combination of bictegravir (B; a second-generation HIV-1 integrase strand transfer inhibitor [INSTI]), and emtricitabine (F) and tenofovir alafenamide (TAF), both nucleoside reverse transcriptase inhibitors (NRTIs), is a recommended initial ART regimen for most people with HIV in the United States. B/F/TAF is an oral, once-daily fixed-dose combination (FDC) that provides a potent and well-tolerated regimen for the treatment of HIV-1 infection in people, including those with some pre-existing resistance and subpopulations that are underrepresented in clinical trials, including Black, Hispanic, and Latine PWH, PWH ≥65 years old, and pregnant adults.
The rapid restart nature of this study involves the concurrent initiation of screening, baseline assessments, and administration of B/F/TAF on the same day. B/F/TAF is the only guideline-recommended single tablet regimen (STR) suitable for rapid restart, as it can be prescribed without prior knowledge of baseline laboratory parameters, including viral load, hepatitis B virus (HBV) status, or baseline genotypic resistance testing. This means the study treatment commences without baseline test results, provided the participant fulfills all eligibility criteria.
There will be two Cohorts of participants within this study: Cohort 1 will include viremic participants (defined by HIV-1 RNA ≥50 copies/mL) at baseline and Cohort 2 will include virologically suppressed participants (defined by HIV-1 RNA <50 copies/mL) at baseline. The study will aim to recruit 125 participants into Cohort 1 while simultaneously recruiting into Cohort 2 (it is assumed approx. 15-75 participants). The ratio of participants in Cohort 1 and Cohort 2 will be monitored during enrollment. Adherence and drop-out rates will be closely monitored throughout the study to mitigate the risk of insufficient sample sizes to power the planned analyses. Each participant's total study participation duration will be up to 48 weeks for data collection. Participants will be followed prospectively for 48 weeks in Cohort 1 and for 24 weeks in Cohort 2. Optional, semi-structured interviews will be conducted for a subset of participants in Cohorts 1 and 2 via teleconference at week 4 and week 24 after baseline screening and treatment reinitiation. While sample size will be informed by theoretical saturation, ~30 participants (15 per Cohort) is estimated to be sufficient.
Achieving viral suppression (defined as HIV-1 RNA <50 copies/mL) is the main goal of ART therapy for PWH who are viremic, and the primary objective of this study. It has been associated with improvements in CD4 cell counts, prevention of HIV drug resistance, AIDS- and non-AIDS-related events, and decreased transmission to sexual partners of PWH. Secondary outcomes include safety, resistance, persistence and adherence, and a range of patient-reported outcomes to understand patient experiences of ART.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, non-randomized study without a control group. The rapid restart nature of this study involves the concurrent initiation of screening, baseline assessments, and administration of B/F/TAF on the same day. The study treatment commences without all baseline test results being available, provided the participant fulfills all eligibility criteria. All eligible participants commence on the same oral, once-daily, fixed-dose combination of B/F/TAF which is a single-tablet regimen of 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). Once baseline assessment of viral load results are available participants are allocated into the relevant cohort which defines the duration of their study intervention. Cohort 1 (48 week follow up) will include viremic participants (HIV-1 RNA ≥50 copies/mL) at baseline and Cohort 2 (24 week follow up) will include virologically suppressed participants (HIV-1 RNA <50 copies/mL) at baseline.
| Arm | Type | Receives |
|---|---|---|
| Open-label B/F/TAF | Experimental | Drug: Bictegravir, emtricitabine, and tenofovir alafenamideAll participants receive open-label B/F/TAF. Treatment duration is determined by baseline viral load: viremic participants (defined by HIV-1 RNA ≥50 copies/mL) at baseline will receive 48 weeks of B/F/TAF; virologically suppressed participants (defined by HIV-1 RNA <50 copies/mL) at baseline will receive 24 weeks of B/F/TAF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
- Returning to care with an interest to restart ART therapy
Key exclusion criteria (10 listed)
- 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
- Known or suspected resistance to BIC (resistance-associated mutations [RAMs] include: G118R, Y143C/H/R, Q148H/K/R, N155H/S, or R263K in the integrase gene)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bictegravir, emtricitabine, and tenofovir alafenamideAlso: B/F/TAF, BIKTARVY®Oral, 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. | Drug | Open-label B/F/TAF |
Primary outcome
Percentage of participants in Cohort 1 with plasma HIV-1 RNA <50 copies/mL
Time frame: Week 24
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
Percentage of participants in Cohort 2 with plasma HIV-1 RNA ≥50 copies/mL
Time frame: Week 24
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
22 secondary outcomes
Percentage of participants with plasma HIV-1 RNA <50 copies/mL
Time frame: 48 weeks
Percentage of participants with plasma HIV-1 RNA <200 copies/mL
Time frame: 48 weeks
Percentage of participants meeting protocol-defined virologic failure (PDVF) criteria in Cohort 1
Time frame: 48 weeks
Percentage of participants meeting PDVF criteria in Cohort 2
Time frame: 24 weeks
Absolute and change from baseline in log10 HIV-1 RNA viral load of participants
Time frame: 48 weeks
Absolute and change from baseline CD4 T-cell count of participants
Time frame: 48 weeks
Percentage of participants discontinuing due to adverse events (AEs) or intolerability
Time frame: 48 weeks
Percentage of participants experiencing treatment-emergent Grade 3-4 laboratory abnormalities
Time frame: 48 weeks
Percentage of participants experiencing treatment-emergent Grade 3-4 drug-related adverse events
Time frame: 48 weeks
Percentage of Participants experiencing Serious Adverse Events (SAEs)
Time frame: 48 weeks
Baseline resistance to B/F/TAF
Time frame: 4 weeks
Treatment-emergent resistance in PDVF participants in Cohort 1
Time frame: 48 weeks
Treatment-emergent resistance in PDVF participants in Cohort 2
Time frame: 24 weeks
Total satisfaction score on the HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs)
Time frame: 48 weeks
Change from Week 4 on the Total HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) score
Time frame: 48 weeks
Total and change from baseline in the symptom distress score on the HIV-Symptom Index (HIV-SI)
Time frame: 48 weeks
Health-related quality of life by EuroQol 5-Dimension 5-Level (EQ-5D-5L) total score and change from baseline
Time frame: Week 4
Reasons for prior ART discontinuation and current reinitiation
Time frame: Baseline
Proportion of participants lost to follow-up
Time frame: Week 48
Proportion of participants on study drug with documented clinic visit
Time frame: Week 48
Adherence to B/F/TAF by pill count or dried blood spot (DBS)
Time frame: Week 48
Participant experiences returning to care after HIV treatment interruption
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be made available to other researchers. This decision is based on considerations related to the vulnerability of the study population and the need to uphold the highest standards of data protection and confidentiality. Given that participants are living with HIV-1, which is a condition associated with significant social, legal, and personal sensitivities, sharing IPD could increase the risk of inadvertent disclosure of sensitive personal information. Ensuring the privacy and protection of identities and health data of participants is essential; therefore, we have decided not to make IPD available for other researchers' use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Altamirano, MD principal investigator
CAN Community Health
Hector Bolivar, MD principal investigator
Midway Specialty Care Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bictegravir, emtricitabine, and tenofovir alafenamide in people with HIV -1 Infection and HIV (Human Immunodeficiency Virus), run by CAN Community Health at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prerak Shukla, MD (941-366-0134 ext. 11102, pshukla@cancommunityhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants in Cohort 1 with plasma HIV-1 RNA <50 copies/mL (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.