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DOR/ISL for HIV
Study Summary
This trial is testing a new drug combination to treat HIV-1 in children who are already on antiretroviral therapy or are treatment-naive. The primary purposes of the study are to examine the drug's pharmacokinetics and safety.
- 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 2023 Phase 3 trial • 35 Patients • NCT04233216Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Under what circumstances is DOR/ISL typically prescribed?
"Patients with no doravirine resistance-associated mutations often find relief through the use of DOR/ISL. This drug combination is also useful in treating conditions like treatment failure, antiretroviral therapy naivety and other forms of antiretroviral therapies."
How many individuals are receiving treatment through the current clinical trial?
"No, this trial has closed its recruitment process. It was first posted on November 26th 2020 and the last update occured on October 13th 2022. For those seeking alternative trials, there are 853 studies that seek patients with infections as well as 21 DOR/ISL clinical studies which remain open to participants."
How many health care facilities are offering this research trial?
"This medical study is enrolling patients from four different sites, such as Emory Children's Center (Site 1805) in Atlanta and Duke University ( Site 1807) in Durham. Additionally, the Children's National Medical Center ( Site 1816) located in Washington is also participating."
What are the chief aims of this clinical research?
"According to Merck Sharp & Dohme Corp., the primary metric of this trial is Apparent total clearance from plasma (CL/F) at Pre-dose, and 4 and 24 hours post-dose on Day 28. Additionally, secondary measurements include Percentage of VS participants with HIV-1 RNA ≥50 copies/mL determined by an Abbott Real Time PCR assay; Percentage of TN participants with HIV-1 RNA <50 copies/mL established via an Abbott Real Time PCR assay; as well as Change from baseline in CD4+ T-cells in VS participants evaluated through a central laboratory."
Does the DOR/ISL treatment pose any hazards to recipients?
"In terms of safety, our team has assigned the drug DOR/ISL a score of 2. This is based on data from its Phase 2 trial which suggests that it is safe to use but there are yet no confirmed benefits associated with it."
Is this experimental research the first of its kind?
"As of now, 21 studies surrounding DOR/ISL are underway in 146 cities and 27 nations. These efforts began back in 2014 when Merck Sharp & Dohme LLC conducted a Phase 3 clinical trial involving 769 participants. Subsequently, 19 more trials have been realized since the initial effort concluded."
What prior investigations have employed DOR/ISL as a research tool?
"Presently, 21 clinical trials concerning DOR/ISL are underway. Of these studies, 9 have advanced to Phase 3 and they are mainly found in Cape Town, Western Cape. However, 348 locations globally provide this treatment regimen."
Is access to this experiment still available for volunteers?
"The latest edit to this medical trial's information on clinicaltrials.gov indicates that it is not accepting new participants, despite initially being posted in November 2020. Nevertheless, 874 other trials are currently seeking volunteers for their research efforts."
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