Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women

Inclusion Criteria:

• 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 thatthe participant has been informed of all pertinent aspects of the trial.

• On stable combination Antiretroviral Therapy (cART) for at least 30 days prior toenrollment

• 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 anyconfounding 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 Criteria:

• Women with multiple gestation, active opportunistic infections, present obstetricalcomplications that would deem them unsuitable for study participation, or evidenceof fetal anomalies in present pregnancy will be excluded.

• Women with severe renal impairment, end stage renal disease, undergoing dialysis, orsevere hepatic impairment (Child-Pugh C)

• Women with a significant illness/condition at the time of enrollment that, in thejudgment of the investigator, would interfere with, or serve as a contraindicationto, 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 (asdetermined by multi-antigen EIA) and detectable HCV RNA.

• Clinically significant labs greater than Grade 2 on the NIH Division of AIDs Tablefor 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 alterpharmacokinetic profiles (atazanavir, maraviroc, darunavir, norvir, efavirenz,tipranavir)

• Receiving moderate to strong cytochrome p450 3A (CYP3A) inhibitors includingclarithromycin, boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir andritonavir, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir andritonavir, paritaprevir and ritonavir, posaconazole, ritonavir, saquinavir andritonavir, telaprevir, tipranavir and ritonavir, grapefruit juice, idelalisib,nefazodone, and nelfinavir.