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.
HPTN 083 open label extension
HPTN 084 open label extension (including pregnancy sub-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.
Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF/FTC bridging may be enrolled following consultation with the Medical Monitor.
Previous premature discontinuation from IP in the parent study/sub-study.
ALT >5 × ULN; or ALT>3 × ULN and bilirubin >1.5 × ULN (with >35% direct bilirubin) in the screening liver chemistry test result.
Participants with known active hepatitis B infection (as indicated by a positive HBsAg and/or quantifiable HBV DNA). Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
Single group
CAB LA
DrugParticipants will receive CAB LA 600 mg via gluteal IM injection, once every 8 weeks (Q8W).
Number of participants with new HIV infection
Number of participants with new HIV infection by characteristic
Relevant characteristics of new HIV infections will be assessed, including presence of viral resistance to CAB.
Number of participants with serious adverse events (SAE) by severity
The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.
Number of participants with Grade 3 and Grade 4 injection site reactions (ISRs)
ISRs may occur following intramuscular administration of CAB LA. Grade 3 refers to severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated. Grade 4 refers to potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death.
Number of participants with any clinical or laboratory AE leading to discontinuation of CAB LA, by severity
Any clinical or laboratory AE that leads the participant to permanently discontinue CAB LA will be assessed. The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.
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