Langetermijnfollow-up van langwerkend cabotegravir (CAB LA) voor PrEP (Pre-exposure profylaxe) bij deelnemers die risico lopen om HIV (Human Immunodeficiency Virus) te krijgen (PALISADE)
Een fase IIIB, langetermijnfollow-up van CAB LA voor deelnemers aan HPTN 083 en HPTN 084 CAB PrEP-onderzoeken met risico op HIV-acquisitie
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.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Almagro, Argentinië, C1427CEA
- GSK Investigational Site
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Buenos Aires, Argentinië, 1221
- GSK Investigational Site
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Francistown, Botswana
- GSK Investigational Site
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Rio de Janeiro, Brazilië, 21040-360
- GSK Investigational Site
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São Paulo, Brazilië, 05403-000
- GSK Investigational Site
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São Paulo, Brazilië, 04121-000
- GSK Investigational Site
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazilië, 91350-200
- GSK Investigational Site
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Kisumu, Kenia, 40100
- GSK Investigational Site
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Blantyre, Malawi
- GSK Investigational Site
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Lilongwe, Malawi, CLW
- GSK Investigational Site
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Entebbe, Oeganda, 49
- GSK Investigational Site
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Kampala, Oeganda
- GSK Investigational Site
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Lima, Peru, 15001
- GSK Investigational Site
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Lima, Peru, 15024
- GSK Investigational Site
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Lima, Peru, 15088
- GSK Investigational Site
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Lima, Peru, Lima 04
- GSK Investigational Site
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Piura, Peru, 20000
- GSK Investigational Site
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Mbabane, Swaziland, H103
- GSK Investigational Site
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Pathum Wan, Thailand, 10330
- GSK Investigational Site
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Chiang Mai
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Chiang Mai, Chiang Mai, Thailand, 50200
- GSK Investigational Site
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Hanoi, Vietnam
- GSK Investigational Site
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Chitungwiza, Zimbabwe, 00263
- GSK Investigational Site
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Chitungwiza, Zimbabwe, 230221
- GSK Investigational Site
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Chitungwiza, Zimbabwe, 263
- GSK Investigational Site
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Harare, Zimbabwe
- GSK Investigational Site
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Cape Town, Zuid-Afrika, 7505
- GSK Investigational Site
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City of Cape Town, Zuid-Afrika, 755
- GSK Investigational Site
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City of Cape Town, Zuid-Afrika, 792
- GSK Investigational Site
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City of Johannesburg, Zuid-Afrika, 2001
- GSK Investigational Site
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Durban, Zuid-Afrika, 4110
- GSK Investigational Site
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Durban, Zuid-Afrika, 4400
- GSK Investigational Site
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Isipingo, Zuid-Afrika, 4110
- GSK Investigational Site
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Sol Plaatjie, Zuid-Afrika, 8301
- GSK Investigational Site
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion criteria:
Type of participant
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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.
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Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.
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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
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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
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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.
Exclusion Criteria:
Concurrent conditions/medical history (includes liver function)
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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.
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Previous premature discontinuation from IP in the parent study/sub-study.
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ALT >5 × ULN; or ALT>3 × ULN and bilirubin >1.5 × ULN (with >35% direct bilirubin) in the screening liver chemistry test result.
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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.
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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).
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Known history of cirrhosis with or without viral hepatitis co-infection.
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Participant is currently participating in or has participated in a study (other than the studies listed in Inclusion Criteria 1) with a compound or device that is not commercially available within 30 days prior to signing informed consent, unless permission from the Medical Monitor is granted.
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Presence of or any history of allergy/sensitivity to the study drug or its components.
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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.
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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.
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Coagulopathy (primary or iatrogenic) which would contraindicate IM injection. Concomitant medications
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Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication.
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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
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Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
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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
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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.
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Participant is a ward of the state (e.g. child in care).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: CAB LA 600 mg (Q8W)
All enrolled participants have previously received CAB LA as part of the HPTN 083 and HPTN 084 parent studies or their sub-studies. Participants will continue receiving CAB LA 600 mg via gluteal intramuscular (IM) injection. |
Participants will receive CAB LA 600 mg via gluteal IM injection, once every 8 weeks (Q8W).
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Aantal deelnemers met nieuwe HIV-infectie
Tijdsspanne: Vanaf dag 1 tot einde studie (tot ongeveer [ongeveer] 3 jaar)
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Vanaf dag 1 tot einde studie (tot ongeveer [ongeveer] 3 jaar)
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Number of participants with new HIV infection by characteristic
Tijdsspanne: From Day 1 up to end of study (up to approx. 3 years)
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Relevant characteristics of new HIV infections will be assessed, including presence of viral resistance to CAB. |
From Day 1 up to end of study (up to approx. 3 years)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of participants with serious adverse events (SAE) by severity
Tijdsspanne: From Day 1 up to end of study (up to approx. 3 years)
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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. |
From Day 1 up to end of study (up to approx. 3 years)
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Number of participants with Grade 3 and Grade 4 injection site reactions (ISRs)
Tijdsspanne: From Day 1 up to end of study (up to approx. 3 years)
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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. |
From Day 1 up to end of study (up to approx. 3 years)
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Number of participants with any clinical or laboratory AE leading to discontinuation of CAB LA, by severity
Tijdsspanne: From Day 1 up to end of study (up to approx. 3 years)
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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. |
From Day 1 up to end of study (up to approx. 3 years)
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Door bloed overgedragen infecties
- Urogenitale ziekten
- Genitale ziekten
- Ziekten van het immuunsysteem
- Infecties
- RNA-virusinfecties
- Virusziekten
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Langzame virusziekten
- HIV-infecties
- Verworven Immunodeficiëntie Syndroom
- cabotegravir
Andere studie-ID-nummers
- 221163
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
IPD-tijdsbestek voor delen
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD-toegangscriteria voor delen
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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