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Antiretroviral
Pharmacokinetic (PK) Tail Phase: F/TDF for Pre-Exposure Prophylaxis (PURPOSE-4 Trial)
Phase 2
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date up to 30 days post last dose at week 78
Awards & highlights
PURPOSE-4 Trial Summary
This trial aims to study how lenacapavir (LEN) moves through the body and assess the safety of LEN and emtricitabine/tenofovir disoproxil f
Who is the study for?
This trial is for people in the US who inject drugs and have shared needles within the last month. They must not have HIV or hepatitis B, should have a kidney function with GFR of at least 60 mL/min, and show recent signs of injection use. A positive drug screen for substances like opioids or stimulants is also required.Check my eligibility
What is being tested?
The study tests how lenacapavir (LEN), given as tablets and injections, moves through the body and its safety when combined with Truvada® (F/TDF) as a preventive treatment against HIV in those who inject drugs.See study design
What are the potential side effects?
While specific side effects are not listed here, typically antiretroviral drugs like LEN and F/TDF can cause symptoms such as nausea, diarrhea, headaches, fatigue, and sometimes more serious effects on liver or kidney health.
PURPOSE-4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by GFR, is 60 mL/min or higher.
PURPOSE-4 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose date up to 30 days post last dose at week 78
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose date up to 30 days post last dose at week 78
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK Parameter: Ctrough for LEN: LEN Plasma concentration at the End of the Dosing Interval (Week 52)
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities with LEN and F/TDF
+1 moreSecondary outcome measures
General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses
Number of Participants with Adherence to F/TDF as Assessed by Adherence Levels Based on Intracellular Tenofovir-diphosphate (TFV-DP) Concentrations in Dried Blood Spot (DBS)
Number of Participants with Adherence to LEN, as Assessed by On-time LEN Injections Received
+2 morePURPOSE-4 Trial Design
3Treatment groups
Experimental Treatment
Group I: Randomized Phase: Lenacapavir (LEN) GroupExperimental Treatment2 Interventions
Participants will receive subcutaneous (SC) LEN 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2.
Group II: Randomized Phase: Emtricitabine/ Tenofovir Disoproxil Fumarate (F/TDF) GroupExperimental Treatment1 Intervention
Participants will receive daily F/TDF (200/300 mg) fixed dose combination (FDC) tablets for up to 52 weeks.
Group III: Pharmacokinetic (PK) Tail Phase: F/TDFExperimental Treatment1 Intervention
After the completion of the Randomized Phase, participants in LEN group will be transitioned to receive F/TDF FDC tablets and participants in F/TDF group will continue to receive F/TDF FDC tablets in the PK Tail Phase. All participants will receive F/TDF FDC tablets, once daily for up to 78 weeks beginning 26 weeks after the last LEN injection.
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,481 Total Patients Enrolled
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,012 Total Patients Enrolled
1 Trials studying Pre-Exposure Prophylaxis
57 Patients Enrolled for Pre-Exposure Prophylaxis
HIV Prevention Trials NetworkNETWORK
30 Previous Clinical Trials
568,454 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are potential participants currently able to apply for enrollment in this ongoing clinical trial?
"Indeed, as per the details found on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible patients. The trial was initially posted on December 13th, 2023 and received its most recent update on December 20th of the same year."
Answered by AI
Has the Food and Drug Administration (FDA) given its approval for the pharmacokinetic tail phase of F/TDF?
"Based on our assessment, the safety rating for the Pharmacokinetic (PK) Tail Phase: F/TDF is 2. This determination is influenced by it being a Phase 2 trial where some evidence exists supporting its safety but not its efficacy."
Answered by AI
What is the current number of participants being recruited for this research study?
"Indeed, the information provided on clinicaltrials.gov confirms that this investigation is actively seeking suitable candidates. The trial was initially posted on December 13th, 2023 and underwent its most recent update on December 20th, 2023. A total of 250 participants are being sought at a single research site."
Answered by AI
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