A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
∙ Type of participant
• Participants must have recently completed or be currently enrolled and ongoing in one of the following studies on the CAB LA arm:
‣ HPTN 083 open label extension
⁃ HPTN 084 open label extension (including pregnancy sub-study)
• Participants that completed study participation ≥3 months ago must be discussed with the Medical Monitor prior to enrolment.
• Participants who have prematurely withdrawn from prior CAB PrEP studies cannot enroll into this study.
• Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.
• Participants must have nonreactive HIV tests at Screening (rapid test, immunoassay \[antigen/antibody\] test and HIV-1 RNA results must all be available and nonreactive) and Day 1 (at least one of rapid test and immunoassay \[antigen/antibody test\] results must be available and nonreactive). Participants who have one or more reactive or positive HIV test result(s) will not be enrolled, even if subsequent confirmatory testing indicates they are not HIV-infected.
• Sex
• Males and Females:
• All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs.
• Females:
• Cisgender female participants who are of childbearing potential and who are engaging in sexual activity that could lead to pregnancy, must talk to the investigator about recommended contraception options. Contraception will be optional in this study. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
• Pregnant participants from the HPTN 084 study are eligible to enroll into this study if they meet all eligibility criteria.
• Informed consent
• Participant or caregiver/legal guardian is able and willing to provide signed informed consent as described in Protocol Section 11.1.5, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Where applicable, participants must provide written assent.