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Lenacapavir for HIV Prevention (PURPOSE 2 Trial)
PURPOSE 2 Trial Summary
This trial will study the effectiveness of a new drug, lenacapavir, in preventing HIV infection in people who are at risk. The trial will have two parts: a cross-sectional study to estimate the background HIV infection rate, and a double-blind, randomized study to study the drug.
PURPOSE 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPURPOSE 2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PURPOSE 2 Trial Design
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- I've had unprotected receptive anal sex with 2 or more partners in the last 3 months.My kidney function, measured by eGFR, is 60 mL/min or higher.You have taken drugs to increase sexual desire or performance in the past 12 weeks.I have acute or chronic hepatitis A, B, or C.I have had syphilis, rectal gonorrhea, or rectal chlamydia in the past 6 months.I have received an HIV vaccine or broadly neutralizing antibody.My condition is in the initial phase.I have had syphilis, rectal gonorrhea, or rectal chlamydia in the past 6 months.My kidney function, measured by eGFR, is 60 mL/min or higher.I have severe liver problems or cirrhosis.I have had unprotected sex with a male partner in the last year.I'm sorry, but the criterion you provided, "Incidence Phase," is not clear enough for me to summarize. Could you please provide more information or context?It seems like you provided a partial criterion. Could you please provide more details or context so that I can accurately summarize it for you?I've had unprotected receptive anal sex with 2 or more partners in the last 3 months.You have used drugs that increase your energy and sex drive in the past 12 weeks.You have not been tested for HIV-1 in the last 3 months and your HIV-1 status is unknown.I am at risk for HIV due to unprotected sex.I am at risk for HIV due to unprotected sex with male partners.I have used oral PrEP or long-acting PrEP in the last 12 weeks.I am participating in a phase of the trial where treatment is assigned randomly.
- Group 1: PK Tail Phase
- Group 2: LEN Open-Label Extension (OLE) Phase
- Group 3: Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF
- Group 4: Blinded Phase: Placebo LEN + F/TDF
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies in this clinical research program?
"Yes, the clinicaltrials.gov website confirms that this trial is open and actively recruiting participants. The study was first posted on June 28th, 2021 and was last updated November 4th, 2022. 61 different centres are looking to enroll a total of 3000 patients."
Is the data on Lenacapavir (LEN) limited to one clinical trial?
"As of right now, 102 clinical trials are underway that focus on Oral Lenacapavir (LEN). Out of those 102 live studies, 32 are in Phase 3. The majority of research surrounding Oral Lenacapavir (LEN) is conducted in Boylston, Massachusetts; however, there are 1,679 locations worldwide where clinical trials for this treatment are taking place."
What infections does Oral Lenacapavir (LEN) help to fight?
"Oral Lenacapavir (LEN) is an effective treatment against human immunodeficiency virus type 1 (HIV-1), HIV infections, and the transmission of HIV."
What is the official position of the FDA on LEN?
"There is pre-existing clinical data supporting the safety of LEN, so it was given a score of 3."
How many people are taking part in this scientific research project?
"This study necessitates 3000 willing and eligible participants. If you meet the requirements, which are detailed on the clinicaltrials.gov website, then you can sign up to participate at various locations such as Centro San Vincente in El Paso, Texas or Henry Ford Hospital in Detroit, Michigan."
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