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Non-Nucleoside Reverse Transcriptase Inhibitor

Doravirine for HIV in Pregnancy

Phase 1

Recruiting

Led By Angela Kashuba, PharmD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant women living with Human Immunodeficiency Virus (HIV) ≥18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment visit to follow-up visit, an average of 10 months.

Awards & highlights

Study Summary

This trial is testing the effects of pregnancy on doravirine concentrations and what dose to use. Participants will stay on their normal antiretroviral medications and go to the clinic for three visits, where they will take one dose of doravirine. The trial is designed not to give a dose during the first trimester, when there is the greatest chance for drugs to harm the baby. Participants may be enrolled for up to 10 months.

Who is the study for?

This trial is for HIV-positive pregnant women over 18, with stable health and on consistent antiretroviral therapy. They must have low viral loads and normal liver function. Women with severe kidney or liver issues, multiple pregnancies, certain other illnesses, or taking drugs that affect the body's drug processing are excluded.Check my eligibility

What is being tested?

The study tests how pregnancy affects the levels of Doravirine (an HIV medication) in the body to determine proper dosing. Participants will take a single dose at different stages of pregnancy and post-delivery while continuing their regular HIV treatments.See study design

What are the potential side effects?

While specific side effects for this trial aren't listed, common ones associated with Doravirine include trouble sleeping, headache, diarrhea, nausea, and abnormal dreams.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a pregnant woman over 18 with HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment visit to follow-up visit, an average of 10 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment visit to follow-up visit, an average of 10 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment visit to follow-up visit, an average of 10 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in total and protein-unbound Area Under the Curve (AUC) of doravirine in blood plasma during pregnancy.

Body Weight Changes

Change in total and protein-unbound C24h of doravirine in blood plasma during pregnancy.

+2 more

Secondary outcome measures

Number of Adverse Events reported after single doses of doravirine in pregnant participants.

Side effects data

From 2020 Phase 3 trial • 15 Patients • NCT04079452

Diarrhea

Thoracic pain

100%

80%

60%

40%

20%

Study treatment Arm

Doravirine+TAF/FTC Arm (Single Arm)

Trial Design

1Treatment groups

Experimental Treatment

Group I: DoravirineExperimental Treatment1 Intervention

100mg doravirine given by mouth once at each sampling visit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doravirine

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,506 Previous Clinical Trials

4,190,551 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,684 Total Patients Enrolled

Angela Kashuba, PharmDPrincipal InvestigatorUNC Chapel Hill

3 Previous Clinical Trials

78 Total Patients Enrolled

Media Library

Doravirine (Non-Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04900974 — Phase 1

Human Immunodeficiency Virus Infection Research Study Groups: Doravirine

Human Immunodeficiency Virus Infection Clinical Trial 2023: Doravirine Highlights & Side Effects. Trial Name: NCT04900974 — Phase 1

Doravirine (Non-Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04900974 — Phase 1

Frequently Asked Questions

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

Are there any significant dangers associated with Doravirine?

"The safety of Doravirine was given a score of 1 because this is only a Phase 1 trial. This means that there is limited data supporting both the safety and efficacy of the medication."

Answered by AI

What are the main indications for Doravirine?

"Doravirine is used to treat patients without doravirine resistance-associated mutations. Additionally, it can be used to manage treatment failure, antiretroviral therapy for naive patients, and other similar conditions."

Answered by AI

What else is known about Doravirine from prior research?

"Currently, there are 17 studies underway that focus on doravirine. 8 of those studies are in their third and final phase. The vast majority of trials for doravirine are located in Philadelphia, Pennsylvania; however, there are 269 total sites running these sorts of medical trials."

Answered by AI

Does this clinical trial represent a new method or type of research?

"There are currently 17 ongoing clinical trials for Doravirine in 24 nations and 121 cities. Merck Sharp & Dohme LLC sponsored the first trial in 2014 which completed Phase 3 drug approval that included 769 patients. Since then, 15 more trials have been conducted."

Answered by AI

Are people currently being signed up to participate in this experiment?

"The trial, as indicated by clinicaltrials.gov is still actively recruiting patients. The posting went up on 6/9/2022 with the most recent edit being made on 8/10/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women

2022. "Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04900974.

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