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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
Must not have
Active hepatitis C (HCV) infection as defined by anti-hepatitis C virus serology (as determined by multi-antigen EIA) and detectable HCV RNA
Women with severe renal impairment, end stage renal disease, undergoing dialysis, or severe hepatic impairment (Child-Pugh C)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment visit to follow-up visit, an average of 10 months.
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.
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.
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
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I am a pregnant woman over 18 with HIV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active hepatitis C infection confirmed by tests.
Select...
I have severe kidney or liver problems.
Select...
I am not taking any medications that affect drug levels, like St. John's wort or rifampin.
Select...
My lab results show no major health issues.
Select...
I am currently taking medication that strongly affects my liver's ability to process drugs.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Number of Adverse Events reported after single doses of doravirine in pregnant participants.

Side effects data

From 2021 Phase 4 trial • 8 Patients • NCT04689737
25%
Vomiting
13%
Cardiac insufficiency
13%
Headache
13%
IQ-RCFI EM Hospitalization for Fibula Fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental Group

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,554 Previous Clinical Trials
4,293,123 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,428 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
~1 spots leftby Mar 2025
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