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Islatravir for HIV
Study Summary
This trial will study the safety and how well the body tolerates and processes islatravir, a potential new HIV prevention drug, given monthly.
- HIV
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 242 Patients • NCT04003103Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Is this survey open to geriatric patients?
"To qualify for this study, applicants must be between 18 and 65 years old. For those younger or older than the specified age range, there are respectively 215 trials and 676 trials available to them."
How many participants are included in this medical experiment?
"At the moment, this research trial is no longer seeking participants. Initially posted on September 19th 2019 and most recently modified on August 24th 2022, any further inquiries should be directed elsewhere. There presently exists 851 studies searching for people with HIV-1 infection and 8 medical trials recruiting Islatravir patients."
What are the eligibility parameters for participating in this medical research?
"This medical trial requires 242 participants aged 18-65 that are HIV-1 positive. Besides meeting the age criteria, applicants must also have a low risk of contracting HIV within the last year, be non pregnant or breastfeeding women not capable of bearing children (WOCBP) and using contraceptive methods or abstinent from intercourse as their primary lifestyle; plus get verified with an unfavorable pregnancy test result."
What specific objectives is this experiment attempting to fulfill?
"The aim of this trial, to be conducted over a span of 68 weeks, is to identify and monitor serious adverse events. The secondary goals entail tracking the maximum concentration (Cmax) post-dose of plasma islatravir in participants, measuring percentage of patients with an AE resulting in death up to week 24, and evaluating the rate of any AEs amongst particpants within that same time frame."
In which geographic regions does this research take place?
"Four centres are actively recruiting for this trial; Research Centers of America, LLC in Hollywood (Site 0007), Magee Womens Research Institute in Pittsburgh ( Site 0001), Johns Hopkins School of Medicine - Drug Development Unit located at Baltimore ( Site 0002) and four additional medical facilities."
Is this experiment actively seeking participants?
"Unfortunately, recruitment for this experiment has been concluded. First posted on September 19th 2019, the last alteration was made to its posting on August 24th 2022. Nonetheless, those seeking clinical trials can find 851 studies recruiting patients with HIV-1 and 8 focused on Islatravir actively searching for participants."
What potential harm could Islatravir pose to humans?
"Considering the Phase 2 status, it is estimated that Islatravir's safety can be rated as a 2 due to available evidence of its security but lack of data demonstrating effectiveness."
Is this an unprecedented clinical trial?
"To date, 8 ongoing trials for Islatravir have been conducted in 133 cities and 25 countries. This drug was first tested as part of a Phase 2 study sponsored by Merck Sharp & Dohme Corp., which enrolled 242 participants back in 2019; since then a total of 18,326 studies have taken place."
What researches have explored Islatravir's potential applications?
"Presently, there are 8 experimental studies utilizing Islatravir with 4 in the third phase of clinical trials. Most research sites for this drug can be found in Cape Town, Western Cape but globally 292 medical centres offer access to these treatments."
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