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New treatment option for HIV -1 Infection
Official title REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE
ClinicalTrials.gov ID: NCT07476339
What this study is testing
What is Bictegravir, emtricitabine, and tenofovir alafenamide?
Bictegravir, emtricitabine, and tenofovir alafenamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hiv -1 infection.
Also referred to as B/F/TAF, BIKTARVY®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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
You likely can't join if
- 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...
- Known/suspected resistance to tenofovir (TFV) (RAMs include: K65R/E/N, or K70E)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Clearwater, Florida, United States
- Ft. Pierce, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Temple Terrace, Florida, United States
- West Palm Beach, Florida, United States
- Wilton Manors, Florida, United States
- Las Vegas, Nevada, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clearwater, Florida, United States; Ft. Pierce, Florida, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States; Temple Terrace, Florida, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.