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REINItiation of Antiretroviral Therapy with Bictegravir, Emtricitabine, and Tenofovir Alafenamide

This study is looking at restarting HIV treatment quickly for people who have stopped taking their medication for at least 12 weeks. It uses a combination pill called bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF), which is a common and effective HIV medicine. The study wants to see how well this medicine works to lower the amount of HIV in the blood (viral load) after 24 weeks. It also aims to understand why people stop and restart their HIV treatment. You might be able to join if you are at least 18 years old, have HIV-1, and have previously taken HIV medicine for at least 30 days but stopped for at least 12 weeks.

Study design
This is an open-label study, meaning you and your doctors will know what medicine you are taking. It will involve about 200 participants and is a single-arm study, so everyone will receive the same treatment.
What's involved
You will take the study medication, bictegravir, emtricitabine, and tenofovir alafenamide, once daily for 24 or 48 weeks. Screening, baseline assessments, and starting the medication will all happen on the same day.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at Week 24, but some participants may continue treatment for 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07476339

REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE

Recruiting
PHASE4Ages 18+InterventionalTreatment
CAN Community Health
~200 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Bictegravir, emtricitabine, and tenofovir alafenamide

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants in Cohort 1 with plasma HIV-1 RNA <50 copies/mL
Measured over Week 24
+1 more outcome measured

Conditions

HIV -1 Infection
HIV (Human Immunodeficiency Virus)
HIV
HIV 1 Infection

Explore related trials

HIV Infection

Where it's being run

10 sites across 2 states
Florida9
Nevada1

Study leadership

  • Jessica Altamirano, MD · PRINCIPAL_INVESTIGATOR · CAN Community Health
  • Hector Bolivar, MD · PRINCIPAL_INVESTIGATOR · Midway Specialty Care Center

Who to contact

Prerak Shukla, MD
[email protected]
941-366-0134 · ext. 11102
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥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

Exclusion

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)
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

What this trial measures

  • Percentage of participants in Cohort 1 with plasma HIV-1 RNA <50 copies/mLWeek 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/mLWeek 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