Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.
Willing and able to provide written informed consent for study participation for self and infant
At screening, age 18 years or older
Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0/7 and 23 6/7 weeks (inclusive) at entry
At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up
History of treatment/virologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)
Has any of the following (1) HIV Subtype A6; (2) History of hypersensitivity reaction (HSR), known or suspected allergy to drugs under study, or any other contraindication to CAB or RPV; (3) Current contraindication to IM injection such as a current inflammatory skin condition that compromises the safety of IM injections or a dermatological condition which may interfere with the interpretation of ISRs; (4) Current use or anticipated need of therapeutic anticoagulation; (5) History of known or suspected bleeding disorder; (6) Current severe hepatic impairment (Class C) as determined by Child-Pugh classification; (7) History of suicidal ideation or attempt within six months of entry; (8) History of unstable or poorly controlled seizure disorder; (9) Current tuberculosis infection; (10) Current cervical intraepithelial neoplasia (CIN) 2 or 3, or malignancy other than Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma
Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta accreta/increta/percreta; (2) Cervical cerclage/cervical incompetence; (3) Abnormal fetal anatomy
Had any of the following in a previous pregnancy: (1) Eclampsia/Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) syndrome; (2) Intrauterine fetal demise (EGA greater than 20 weeks) without known nonrecurrent etiology; (3) Spontaneous very preterm delivery (less than 32 weeks); (4) Very LBW (less than 1500 g); (5) Cervical or abdominal cerclage due to cervical incompetence
Pregnant women with HIV viral suppression in the United States, age 18 years and older, who initiated CAB LA + RPV LA pre- or post-conception, with an estimated gestational age from 10 0/7 weeks through 23 6/7 weeks at time of entry, and their infants.
Other
Prospective
Every 4-week long-acting injectable cabotegravir and rilpivirine
DrugLong-acting injectable cabotegravir and rilpivirine, initiated pre- or post-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum
Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Percentage of adult participants with virologic escape
Percentage of adult participants with virologic escape, defined as a single measurement of HIV RNA greater than or equal to 200 copies/mL
Percentage of adult participants with confirmed virologic failure
Percentage of adult participants with confirmed virologic failure, defined as two successive HIV RNA test results greater than or equal to 200 copies/mL from separate specimens collected at least two weeks apart
Number of adult participants with HIV resistance to CAB or RPV who had confirmed virologic failure
Number of adult participants with HIV resistance to CAB or RPV using IAS-USA, in participants who experienced confirmed virologic failure
Click on the lead sponsor to view all of their trials.
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
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