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Non-nucleoside reverse transcriptase inhibitor

Doravirine for Pediatric HIV

Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight is >3 kg to <45 kg
Has treatment history defined as either TN or with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months on combination antiretroviral therapy (cART)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 predose, week 4 predose, week 8 random, week 12 random, and week 24 predose and 0.5-2 hours postdose
Awards & highlights

Study Summary

This trial is evaluating the safety and efficacy of an experimental drug for HIV in children.

Who is the study for?
This trial is for HIV-infected children from 4 weeks to under 12 years old, weighing less than 45 kg. They must be either new to treatment or have had their virus levels controlled for at least three months without any history of treatment failure. Girls who can have babies must not be pregnant, breastfeeding, and should use birth control or practice abstinence.Check my eligibility
What is being tested?
The study tests Doravirine (DOR), an HIV medication, in combination with two other antiretroviral drugs (NRTIs) in young patients. It aims to understand how the body processes DOR and assess its safety over a period of up to six months.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with antiretrovirals like Doravirine may include nausea, headache, fatigue, diarrhea and potential liver issues. The trial will monitor these and other possible adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is between 3 kg and 45 kg.
Select...
I am HIV positive and have been on effective treatment for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 predose, week 4 predose, week 8 random, week 12 random, and week 24 predose and 0.5-2 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 predose, week 4 predose, week 8 random, week 12 random, and week 24 predose and 0.5-2 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve from 0 to 24 hours postdose (AUC0-24hr) of DOR with 2 NRTIs in plasma at steady-state
Concentration at 24 hours (C24) of DOR with 2 NRTIs in plasma at steady-state
Maximum concentration (Cmax) of DOR with 2 NRTIs in plasma at steady-state
+5 more
Secondary outcome measures
AUC0-24hr of 3TC
AUC0-24hr of TFV
Assessment of palatability/acceptability of DOR pellets/granules
+21 more

Side effects data

From 2020 Phase 3 trial • 15 Patients • NCT04079452
7%
Diarrhea
7%
Thoracic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Doravirine+TAF/FTC Arm (Single Arm)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Doravirine + 2 NRTIsExperimental Treatment2 Interventions
Participants receive DOR (3.2 mg to 100 mg based on weight) in combination with 2 NRTIs (based on local label) for 96 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doravirine
2012
Completed Phase 4
~1390

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,736 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,868 Previous Clinical Trials
5,051,769 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,770 Previous Clinical Trials
8,061,882 Total Patients Enrolled

Media Library

Doravirine (Non-nucleoside reverse transcriptase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04375800 — Phase 2
HIV/AIDS Research Study Groups: Doravirine + 2 NRTIs
HIV/AIDS Clinical Trial 2023: Doravirine Highlights & Side Effects. Trial Name: NCT04375800 — Phase 2
Doravirine (Non-nucleoside reverse transcriptase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375800 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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+."

Answered by AI

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."

Answered by AI
~46 spots leftby Mar 2028