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Doravirine for Pediatric HIV
Study Summary
This trial is evaluating the safety and efficacy of an experimental drug for HIV in children.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 15 Patients • NCT04079452Trial Design
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Who is running the clinical trial?
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- I understand the study details and agree to continue treatment as advised for up to 224 weeks.I am not taking, nor do I need, any drugs that weaken my immune system.I have had cancer before.I am not pregnant or breastfeeding, and if I can have children, I use contraception or practice abstinence.I have kidney disease.I have an active infection related to AIDS.I have an active hepatitis diagnosis.I have signs or tests showing pancreatitis.My doctor thinks I should get more treatment with DOR and 2 NRTIs.My doctor thinks my treatment with DOR and 2 NRTIs, or DOR/3TC/TDF, was effective by Week 96.I have had a high HIV viral load despite being on HIV medication for over 3 months.My weight is between 3 kg and 45 kg.I am currently being treated for active tuberculosis.I cannot take medicine in the form of oral pellets or granules due to a medical condition.I am HIV positive and have been on effective treatment for at least 3 months.I have liver disease.
- Group 1: Doravirine + 2 NRTIs
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the ultimate goals of this research endeavor?
"As specified by the clinical trial's sponsor, Merck Sharp & Dohme LLC, the primary objective is to measure and assess Percentage of patients that discontinue their treatment due to drug-related adverse events (AEs). This will be done over a 42 day period with measurements taken predose and 1, 2, 4, 12, and 24 hours postdose. Additionally this study also seeks to evaluate secondary outcomes such as: Percentage of naive participants who experience a log10 change from baseline in Human Immunodeficiency Virus type 1 Ribonucleic Acid (HIV-1 RNA) levels; percentage of individuals with HIV-1"
What clinical conditions is Doravirine commonly utilized for?
"Doravirine is viable for treating those with no doravirine resistance-associated mutations, treatment failure, and without pre-existing antiretroviral medication."
Are participants currently being recruited for this research?
"Affirmative, clinicaltrials.gov shows that this research project, which was first advertised on February 3rd 2021 is still recruiting patients. 84 participants are needed at 1 site to complete the trial."
Has such a medical experiment been conducted before?
"There are currently 16 ongoing clinical trials for Doravirine across 24 countries and 121 cities. The first trial, sponsored by Merck Sharp & Dohme LLC, was completed in 2014 after enrolling 769 participants into its Phase 3 stage of drug approval process. Since then an additional 15 studies have been performed."
What is the scope of enrollment for this clinical trial?
"Affirmative, the information provided on clinicaltrials.gov implies that this research is actively seeking participants. This study was first posted on February 3rd 2021 and last updated on August 23rd 2022; it has been mandated to recruit 84 patients from a single site."
Has the United States Food and Drug Administration validated Doravirine as a viable therapeutic?
"With Phase 2 data suggesting safety, but no evidence of efficacy yet, Doravirine has been awarded a score of 2 on the risk scale."
Does this research trial accommodate individuals aged 25 and above?
"To qualify for this trial, one must be between 4 weeks and 11 years old. Clinicaltrials.gov currently lists 197 clinical trials that accept minors and 506 that are limited to senior citizens aged 65+."
Is there an opportunity to partake in this medical exploration?
"In order to be included in this medical study, participants must have HIV and aged between 4 weeks old and 11 years of age. This clinical trial is currently searching for about 84 individuals."
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