Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

Egyéb feltételek

• Parent Tshireletso Study Inclusion Criteria:
• Female 18 years of age or older and willing and able to provide an informed consent
• < 14 days after delivery (calendar day of birth = day 0)
• Negative HIV screening test (conducted at the time of enrolment)
• Female <30 years old or has had < 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)
• Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months; Parent Tshireletso Study Exclusion Criteria
• Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (>1 dose oral/IV), or St. John's wort
• Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)
• Previous hypersensitivity reaction to CAB or other INSTI
• Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months
• Plan for pediatric and post-partum care outside the government system (private clinics)
• Inflammatory skin condition that compromises the safety of the intramuscular injection
• Weight <35kg; Parent Doris Duke Study Inclusion Criteria Post-partum females included
• if HIV-uninfected or unknown HIV status, willing to be tested for HIV
• if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen
• maternal age >18 years,
• ability to speak English or Setswana
• intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery
• have access to a cell phone (including phone of friend or relative); Parent Doris Duke Study Exclusion Criteria Post-partum females excluded if
• did not attend antenatal care or were not included in Tsepamo surveillance
• maternal age <18,
• females who do not speak English or Setswana,
• unable or unwilling to give consent
• will not be able to attend follow up at a study site
• do not have access to any cell phone for follow up calls; Additional Inclusion Criteria for this PK Study
• For DMPA and ETG implant groups, intends to initiate or continue use of DMPA or ETG implant for at least another three or six months, respectively,
• For the CAB-LA groups, have received at least three consecutive CAB injections on time, including the one administered concurrently while starting a contraceptive method,
• Willing to undergo phlebotomy every 4 weeks for the duration of the sub-study period Additional Exclusion Criteria for this PK Study
• Use or anticipated use of nicotine-containing products (e.g., cigarettes or hookahs) known to interact with CAB-LA for the duration of the sub-study period 2) Use within the previous 90 days, current use, or planned future concomitant use of other hormonal contraceptives, including oral contraceptive methods 3) BMI≥35 4) Has any of the following laboratory abnormalities within the last year:
• Serum ALT>5x ULN at the time of screening,
• Serum creatinine >2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI/designee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study