Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
- Conditions
- HIV InfectionsPregnancy Related
- Registration Number
- NCT04900974
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Pregnant women living with Human Immunodeficiency Virus (HIV) =18 years of age<br><br> - Willing and able to comply with scheduled visits, treatment plan, laboratory tests,<br> and other trial procedures.<br><br> - Evidence of a personally signed and dated informed consent document indicating that<br> the participant has been informed of all pertinent aspects of the trial.<br><br> - On stable combination Antiretroviral Therapy (cART) for at least 30 days prior to<br> enrollment<br><br> - Plasma HIV RNA < 50 copies/mL within 90 days prior to enrollment<br><br> - Ability and willingness of participant to not change their cART regimen to avoid any<br> confounding of pharmacokinetic (PK) parameters.<br><br> o Note: Women who change cART regimens will be replaced.<br><br> - Aspartate aminotransferase and alanine aminotransferase < 3x Upper Limit of Normal<br> (ULN)<br><br> - Hemoglobin lower than Division of AIDs (Acquired Immunodeficiency Syndrome) (DAIDs)<br> Grade 2 (9.0 g/dL)<br><br>Exclusion Criteria:<br><br> - Women with multiple gestation, active opportunistic infections, present obstetrical<br> complications that would deem them unsuitable for study participation, or evidence<br> of fetal anomalies in present pregnancy will be excluded.<br><br> - Women with severe renal impairment, end stage renal disease, undergoing dialysis, or<br> severe hepatic impairment (Child-Pugh C)<br><br> - Women with a significant illness/condition at the time of enrollment that, in the<br> judgment of the investigator, would interfere with, or serve as a contraindication<br> to, protocol adherence or assessment of safety.<br><br> - Women with pregnancies that have become complicated are excluded for safety reasons.<br><br> - Active hepatitis C (HCV) infection as defined by anti-hepatitis C virus serology (as<br> determined by multi-antigen EIA) and detectable HCV RNA.<br><br> - Clinically significant labs greater than Grade 2 on the NIH Division of AIDs Table<br> for Grading the Severity of Adult and Pediatric Adverse events<br><br> - Receiving CYP3A inducers including carbamazepine, phenobarbital, phenytoin,<br> enzalutamide, rifampin, rifapentine, mitotane, or St. John's wort or other drugs,<br> including antiretrovirals, that influence drug concentration or alter<br> pharmacokinetic profiles (atazanavir, maraviroc, darunavir, norvir, efavirenz,<br> tipranavir)<br><br> - Receiving moderate to strong cytochrome p450 3A (CYP3A) inhibitors including<br> clarithromycin, boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and<br> ritonavir, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and<br> ritonavir, paritaprevir and ritonavir, posaconazole, ritonavir, saquinavir and<br> ritonavir, telaprevir, tipranavir and ritonavir, grapefruit juice, idelalisib,<br> nefazodone, and nelfinavir.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in total and protein-unbound Cmax of doravirine in blood plasma during pregnancy.;Change in total and protein-unbound Tmax of doravirine in blood plasma during pregnancy.;Change in total and protein-unbound C12h of doravirine in blood plasma during pregnancy.;Change in total and protein-unbound C24h of doravirine in blood plasma during pregnancy.;Change in total and protein-unbound Area Under the Curve (AUC) of doravirine in blood plasma during pregnancy.
- Secondary Outcome Measures
Name Time Method Number of Adverse Events reported after single doses of doravirine in pregnant participants.