F/TAF Tablets for HIV Prevention
(DD-PrEP: Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the body processes (pharmacokinetics) a single dose of two F/TAF tablets, which researchers are studying for HIV prevention. The study examines how these tablets function in the body over 14 days. Individuals in good health, who have not recently used oral PrEP, and have a non-reactive HIV test may qualify for this trial. Participants should be willing to use condoms and refrain from taking other PrEP medications during the study. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Studies have shown that Tenofovir Alafenamide (TAF) is generally easy for most people to tolerate. Research suggests that TAF is safer for the kidneys compared to a similar drug, Tenofovir Disoproxil Fumarate (TDF), indicating it might be gentler on the body over time.
However, some considerations are important. Some people using TAF have reported weight gain. Additionally, a small percentage (2.2%) developed high blood pressure within two years of starting TAF for HIV prevention.
This study is in its early stages and aims to understand how the body processes TAF. While safety information is still being gathered, past research shows TAF is generally manageable for most people. Keep these points in mind when considering joining the trial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Tenofovir Alafenamide (TAF) for HIV prevention because it offers a new approach compared to current options like Tenofovir Disoproxil Fumarate (TDF). Unlike TDF, TAF is designed to be more potent at lower doses, potentially reducing side effects like kidney damage and bone loss. This could make TAF a safer option for long-term use in preventing HIV. Additionally, the one-time dosing of two F/TAF tablets might offer a more convenient regimen for users, enhancing adherence and overall effectiveness.
What evidence suggests that this treatment might be an effective treatment for HIV prevention?
Research has shown that Tenofovir Alafenamide (TAF) effectively lowers the risk of HIV infection. In this trial, participants will receive a one-time dose of two F/TAF tablets. Studies have found that using TAF as a preventive measure before HIV exposure (known as PrEP) greatly reduces the risk of contracting the virus. Real-world evidence supports its high effectiveness and safety, with many users reporting high satisfaction. TAF has proven to maintain strong control over the virus. Although some studies mention higher rates of blood fat issues with TAF, its overall benefits for preventing HIV remain very promising.56789
Who Is on the Research Team?
Sunil Solomon, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This clinical trial is for healthy volunteers interested in HIV prevention. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need to be within a certain age range.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time dosing of two F/TAF tablets
Pharmacokinetic Monitoring
Intensive pharmacokinetic monitoring occurs right after dose administration, becoming sparser over the next 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tenofovir Alafenamide [TAF]
Trial Overview
The study is testing the effects of taking two tablets of F/TAF (tenofovir alafenamide 50 mg/emtricitabine 400mg) just once. Researchers will monitor how this medication moves through and affects the body over two weeks.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Received one-time dosing of two F/TAF tablets
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Effectiveness, safety, and patient-reported outcomes of ...
Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.
Tenofovir alafenamide fumarate use for HIV pre-exposure ...
Both regimens have been shown to significantly reduce the risk of HIV acquisition4,5. Compared with TDF, TAF could achieve more sustained and ...
NCT02842086 | Study to Evaluate the Safety and Efficacy ...
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men.
Effectiveness and safety of tenofovir alafenamide fumarate ...
Conclusions. Virological outcomes were similar across drugs. Rates of any grade laboratory events were highest on TAF, driven by higher rates of lipid events.
5.
infectiousdiseaseadvisor.com
infectiousdiseaseadvisor.com/news/long-term-daily-prep-with-emtricitabine-tenofovir-alafenamide-for-hiv-prevention/Long-Term Daily PrEP With FTC/TAF Highly Effective for ...
Overall, 63% of the HIV diagnoses occurred among patients initially assigned to FTC/TDF and 37% occurred among those initially assigned to FTC/ ...
A Systematic Literature Review and Meta-Analysis
This synthesis of RCT results supports a comparative renal safety advantage of TAF over TDF when evaluated across a broad and diverse range of people.
Reassuring long-term safety, resistance, and efficacy data ...
However, with continuous exposure to cabotegravir, there was a two-thirds reduction in the risk of HIV acquisition compared with oral ...
Use of Tenofovir Alafenamide Fumarate for HIV Pre ...
Among those taking TAF, 8 (2.2%) developed incident hypertension within 2 years of PrEP initiation. In comparison, 1.3% (95% CI, 1.0%-1.7%) of ...
Effectiveness and safety of tenofovir alafenamide ...
TAF/FTC/BIC showed low virological failure in newly diagnosed people with HIV. Estimated TAF/FTC/BIC durability was 84.8% at 12 months, 75.5% at 24 months.
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