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An Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials

11 april 2022 uppdaterad av: HIV Vaccine Trials Network

A Descriptive and Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials

An observational study of long-term outcomes of HIV-1 infection in persons who become infected after enrollment in HIV-1 vaccine trials

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

A descriptive and observational study of long-term outcomes of HIV-1 infection in persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials

Studietyp

Observationell

Inskrivning (Faktisk)

209

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Dominikanska republiken
      • Santo Domingo, Dominikanska republiken
        • Unidad de Vacunas IDCP-COIN-DIGECITSS CRS
  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294
        • Alabama Vaccine CRS
    • California
      • San Francisco, California, Förenta staterna, 94143
        • Bridge HIV CRS
    • Georgia
      • Decatur, Georgia, Förenta staterna, 30030
        • The Hope Clinic of the Emory Vaccine Center CRS
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60612
        • UIC Project Wish CRS
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115-6110
        • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
      • Boston, Massachusetts, Förenta staterna, 02215-4302
        • Fenway Health Clinical Research Site CRS
    • New York
      • New York, New York, Förenta staterna, 10003
        • NY Blood Ctr./Union Square CRS
      • New York, New York, Förenta staterna, 10032-3732
        • Columbia P&S CRS
      • New York, New York, Förenta staterna, 10455
        • NY Blood Ctr./Bronx CRS
      • New York, New York, Förenta staterna, 14642
        • University of Rochester Vaccines to Prevent HIV Infection CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Penn Prevention CRS
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232-2582
        • Vanderbilt Vaccine (VV) CRS
    • Washington
      • Seattle, Washington, Förenta staterna, 98109-1024
        • Seattle Vaccine and Prevention CRS
  • Haiti
      • Port-au-Prince, Haiti, HT-6110
        • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
  • Peru
    • Maynas
      • Iquitos, Maynas, Peru, 1
        • ACSA CRS
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Maternal-Infant Studies Center (CEMI) CRS
  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 1862
        • Soweto HVTN CRS
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, Sydafrika, 4013
        • eThekwini CRS
    • North West Province
      • Klerksdorp, North West Province, Sydafrika, 2571
        • Aurum Institute Klerksdorp CRS
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7750
        • Emavundleni CRS

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Both vaccine and placebo recipients in HVTN trials in which HIV infection constitutes an endpoint (eg, test-of-concept, phase 2 and 3) who become HIV-1 infected after enrollment in the parent study and who meet the inclusion criteria may be offered enrollment in the study.

Beskrivning

Inclusion Criteria:

  • Participants must meet the following criteria in order to be eligible for inclusion in the study:

    1. Confirmation of HIV-1 infection after enrollment in an HVTN vaccine trial in which HIV-1 infection constituted an endpoint, according to the diagnostic algorithm specified in the parent protocol.
    2. Ability and willingness to provide written informed consent to participate in the study.
    3. Ability and willingness to adhere to the on-study follow-up schedule.
    4. Ability and willingness to provide adequate information for locator purposes.
    5. Participants who are currently on ART or who previously received antiretrovirals as part of post-exposure prophylaxis, pre-exposure prophylaxis, or previous treatment regimen will be eligible for inclusion in this protocol. Their previous treatment history will be collected. If a participant has been on ART for more than 2 years, please consult with the protocol team leadership prior to enrollment.

    6. For participants initiating ART, agreement of participant and PHCP to initiate potent and durable ART regimens in accordance with local and international guidelines. Examples of potent and durable regimens are provided in Appendix H. Participants who initiate ART not consistent with regimens outlined in Appendix H may enroll with permission of the protocol chair or designee(s).

      Exclusion Criteria:

  • Persons who meet the following criteria will be excluded from the study:

    1. Any medical, psychiatric, alcohol/drug dependency or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a participant's ability to give informed consent.
    2. Participants who meet these additional criteria will be excluded from the study:
  • Participants undergoing acute therapy for serious medical illnesses (in the opinion of the site investigator) within 14 days prior to initiation of ART.
  • Participants with chronic, acute, or recurrent infections that are serious (in the opinion of the site investigator).
  • Participants who must continue with chronic (maintenance) therapy (e.g., tuberculosis [TB], pneumocystis pneumonia [PCP]), must have completed at least 14 days of therapy and be clinically stable prior to initiation of ART.
  • Oral and vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses, as defined by the site investigator, present no restriction to eligibility.
  • Participants undergoing radiation therapy, systemic chemotherapy, or receiving an immunomodulator within 45 days prior to initiation of ART. (A tapering course of corticosteroids as acute therapy for PCP or other conditions is an exception.)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Participants infected with HIV-1
Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials
Övrig: Observation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Measure plasma HIV-1 RNA levels and CD4+ T cell counts longitudinally
Tidsram: 8 years
Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
8 years
Measure time to initiation of ART
Tidsram: 8 years
Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
8 years
Measure time to HIV-1 related clinical events
Tidsram: 8 years

Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

Responses from ELISpot assays will be reported as the number of spot-forming cells Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
8 years
Proportion of individuals with plasma HIV-1 RNA level <50 copies/mL at 24 weeks after initiation of ART
Tidsram: 8 years

Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

Responses from ELISpot assays will be reported as the number of spot-forming cells Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
8 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons
Tidsram: 8 years
Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
8 years
Occurrence of HIV/AIDS associated events, including death
Tidsram: 8 years
Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
8 years
Proportion of subjects with HIV-1 RNA level <50 copies/mL post-initiation of ART; log change in plasma HIV-1 RNA levels and change in CD4+ T cell levels between baseline (at initiation of ART) and post-initiation of ART
Tidsram: 24, 48, 96, and 144 weeks
Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
24, 48, 96, and 144 weeks
Adherence information collected at 24, 48, 96, and 144 weeks following initiation of ART
Tidsram: 24, 48, 96, and 144 weeks
Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
24, 48, 96, and 144 weeks
Side effects collected at 24, 48, 96, and 144 weeks following initiation of ART
Tidsram: 24, 48, 96, and 144 weeks
Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.
24, 48, 96, and 144 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

HIV Vaccine Trials Network

Utredare

  • Studiestol: Magdalena Sobieszcyk, Columbia University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 juli 2008

Primärt slutförande (Faktisk)

11 juli 2015

Avslutad studie (Faktisk)

1 juli 2016

Studieregistreringsdatum

Först inskickad

7 november 2017

Först inskickad som uppfyllde QC-kriterierna

7 november 2017

Första postat (Faktisk)

9 november 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HVTN 802

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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