HIV/AIDS
Conditions
Interventions
Standard of Care antiretroviral therapy
Longacting Injectable Arm LAI
Sponsors
University of Cape Town
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria to be eligible for enrolment into the study: • HIV-antibody positive pregnant woman. • Age 16 years and over. • Second trimester at enrolment (by clinical evaluation). • No prior failure to DTG, efavirenz (EFV) or nevirapine (NVP)-containing regimen. • Singleton pregnancy, and otherwise uncomplicated. • Willing to receive long-acting injectable ART regimen. • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. • Evidence of a personally signed and dated ICF indicating that the participant has been informed of all pertinent aspects of the study.
Exclusion criteria
Exclusion criteria: Participants presenting with any of the following will not be included in the study: • Prior exposure to NNRTI-based therapy in previous 12 months. • Evidence of prior resistance test with NNRTI and/or INSTI drug resistance mutations. • Elevations in serum levels of alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) or ALT >3xULN and bilirubin (BRN) >2xULN (with >35% direct BRN). • Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for Hepatitis B surface antigen (HBsAg). • Estimated glomerular filtration rate (eGFR) <60mL/min* • Serum haemoglobin < 7.0g/dL* • Current or anticipated need for chronic anticoagulation therapy which would preclude IM injections. • Receiving any of the following medications (current or within past 2 weeks): rifampicin, rifapentine, St John’s Wort, carbamazepine, phenytoin, oxcarbazine, or other drugs known to significantly interact. • Known rilpivirine or cabotegravir resistance-associated mutations. • Known allergies, hypersensitivity, or intolerance to cabotegravir or rilpivirine or their components. • Known cardiac arrhythmia, or long QT syndrome. • Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant’s ability to comply with the dosing schedule or which may compromise the safety of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate antiviral activity and impact on retention in HIV care of temporarily switching to CAB/RPV LA compared with continuation of daily oral ART | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterise the elimination of CAB/RPV and explore safe discontinuation of a CAB/RPV LA regimen;To explore early postpartum PK of CAB/RPV in maternal plasma and breastmilk and infant plasma;To characterise drug exposure in breast milk, and drug transfer to infants through breastfeeding | — |
Countries
South Africa, Uganda
Contacts
Public ContactDaphne Morale
Project Manager Desmond Tutu HIV Centre UCT
Outcome results
None listed