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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 de abril de 2022 actualizado por: 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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

Tipo de estudio

De observación

Inscripción (Actual)

209

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Participants infected with HIV-1
Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials
Otro: Observación

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measure plasma HIV-1 RNA levels and CD4+ T cell counts longitudinally
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

HIV Vaccine Trials Network

Investigadores

  • Silla de estudio: Magdalena Sobieszcyk, Columbia University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de julio de 2008

Finalización primaria (Actual)

11 de julio de 2015

Finalización del estudio (Actual)

1 de julio de 2016

Fechas de registro del estudio

Enviado por primera vez

7 de noviembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

7 de noviembre de 2017

Publicado por primera vez (Actual)

9 de noviembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de abril de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

11 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HVTN 802

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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