Status:
COMPLETED
Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to evaluate the effect of body changes in pregnancy on doravirine concentrations, to determine what dose of doravirine should be used. Study participants will rem...
Detailed Description
Antiretroviral (ARV) medications are used to treat infection with human immunodeficiency virus (HIV). During pregnancy, ARV therapy keeps women healthy and decreases the spread of HIV to their babies ...
Eligibility Criteria
Inclusion
- Pregnant women living with Human Immunodeficiency Virus (HIV) ≥18 years of age
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the trial.
- On stable combination Antiretroviral Therapy (cART) for at least 30 days prior to enrollment
- Plasma HIV RNA \< 50 copies/mL within 90 days prior to enrollment
- Ability and willingness of participant to not change their cART regimen to avoid any confounding of pharmacokinetic (PK) parameters.
- o Note: Women who change cART regimens will be replaced.
- Aspartate aminotransferase and alanine aminotransferase \< 3x Upper Limit of Normal (ULN)
- Hemoglobin lower than Division of AIDs (Acquired Immunodeficiency Syndrome) (DAIDs) Grade 2 (9.0 g/dL)
Exclusion
- Women with multiple gestation, active opportunistic infections, present obstetrical complications that would deem them unsuitable for study participation, or evidence of fetal anomalies in present pregnancy will be excluded.
- Women with severe renal impairment, end stage renal disease, undergoing dialysis, or severe hepatic impairment (Child-Pugh C)
- Women with a significant illness/condition at the time of enrollment that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or assessment of safety.
- Women with pregnancies that have become complicated are excluded for safety reasons.
- Active hepatitis C (HCV) infection as defined by anti-hepatitis C virus serology (as determined by multi-antigen EIA) and detectable HCV RNA.
- Clinically significant labs greater than Grade 2 on the NIH Division of AIDs Table for Grading the Severity of Adult and Pediatric Adverse events
- Receiving CYP3A inducers including carbamazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, or St. John's wort or other drugs, including antiretrovirals, that influence drug concentration or alter pharmacokinetic profiles (atazanavir, maraviroc, darunavir, norvir, efavirenz, tipranavir)
- Receiving moderate to strong cytochrome p450 3A (CYP3A) inhibitors including clarithromycin, boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and ritonavir, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir, posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, grapefruit juice, idelalisib, nefazodone, and nelfinavir.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04900974
Start Date
June 9 2022
End Date
April 8 2025
Last Update
May 26 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514