Resumen

El propósito de este estudio es la evaluación a largo plazo de cabotegravir de acción prolongada inyectable (CAB LA) para la profilaxis preexposición (PrEP) al VIH en participantes elegibles que hayan completado los estudios HPTN 083 y HPTN 084 patrocinados por la División de SIDA (DAIDS) y los subestudios asociados. Los participantes continuarán recibiendo CAB LA y serán seguidos para nuevos diagnósticos de VIH, eventos adversos graves (EAG), reacciones en el sitio de inyección (RSI) de grado 3 y grado 4, y eventos adversos (EA) que lleven a la retirada.

Elegibilidad

Sexo: ALL

Criterios de inclusión

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Participants who have prematurely withdrawn from prior CAB PrEP studies cannot enroll into this study.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.
Presence of or any history of allergy/sensitivity to the study drug or its components.
Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator. Mild skin conditions may not be exclusionary at the discretion of the investigator or designee.
Participant has a gluteal implant, tattoo or other dermatological condition overlying the buttock region which in the opinion of the investigator or designee may interfere with the injection or interpretation of ISRs.
Coagulopathy (primary or iatrogenic) which would contraindicate IM injection. Concomitant medications
Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication.
Anticipated need for HCV therapy with interferon or any drugs that have potential for adverse drug: drug interactions with study treatment throughout the entire study period.
Relevant habits
Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
Any condition (i(including but not limited to substance use disorder) that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
Other
Participant has in the last 14 days prior to screening presented with signs and symptoms, which, in the opinion of the investigator, are suggestive of acute HIV infection. Participants may only be enrolled if clinical suspicion of HIV is ruled out with non-reactive results using appropriate HIV tests as per Inclusion Criterion #3.
Participant is a ward of the state (e.g. child in care).

Criterios de exclusión

Concurrent conditions/medical history (includes liver function)
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.
Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator).
Known history of cirrhosis with or without viral hepatitis co-infection.

Estudio de fase IIIB de seguimiento a largo plazo de CAB LA para participantes de los estudios HPTN 083 y HPTN 084 de PrEP con CAB en riesgo de adquisición del VIH

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

CAB LA

Ubicaciones

GSK Investigational Site

GSK Investigational Site

Patrocinadores

Contactos

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center