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

RecruitingPhase 4Ages 18 Years - anyAllCAN Community Health
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In plain words

What the trial is, and whether it could suit you

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 harde

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * ≥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 Criteria: * 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
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What it tests

  • Bictegravir, emtricitabine, and tenofovir alafenamide
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Where

10 sites
CAN Community Health
Clearwater, United States
Midway Specialty Care Center
Ft. Pierce, United States
CAN Community Health
Jacksonville, United States
CAN Community Health
Orlando, United States
Midway Specialty Care Center
Orlando, United States
CAN Community Health
Tampa, United States
Midway Specialty Care Center
Temple Terrace, United States
Midway Specialty Care Center
West Palm Beach, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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