- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03337906
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
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
Visão geral do estudo
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
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
-
-
-
-
-
Port-au-Prince, Haiti, HT-6110
- Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
-
-
-
-
Maynas
-
Iquitos, Maynas, Peru, 1
- ACSA CRS
-
-
-
-
-
San Juan, Porto Rico, 00935
- Maternal-Infant Studies Center (CEMI) CRS
-
-
-
-
-
Santo Domingo, República Dominicana
- Unidad de Vacunas IDCP-COIN-DIGECITSS CRS
-
-
-
-
Gauteng
-
Johannesburg, Gauteng, África do Sul, 1862
- Soweto HVTN CRS
-
-
Kwa Zulu Natal
-
Durban, Kwa Zulu Natal, África do Sul, 4013
- eThekwini CRS
-
-
North West Province
-
Klerksdorp, North West Province, África do Sul, 2571
- Aurum Institute Klerksdorp CRS
-
-
Western Cape
-
Cape Town, Western Cape, África do Sul, 7750
- Emavundleni CRS
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
Participants must meet the following criteria in order to be eligible for inclusion in the study:
- 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.
- Ability and willingness to provide written informed consent to participate in the study.
- Ability and willingness to adhere to the on-study follow-up schedule.
- Ability and willingness to provide adequate information for locator purposes.
- 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.
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:
- 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.
- 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.)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Participants infected with HIV-1
Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Measure plasma HIV-1 RNA levels and CD4+ T cell counts longitudinally
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Patrocinador
Investigadores
- Cadeira de estudo: Magdalena Sobieszcyk, Columbia University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HVTN 802
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Infecções por HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecrutamentoHIV | Teste de HIV | Ligação do HIV ao Cuidado | Tratamento de HIVEstados Unidos
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement e outros colaboradoresDesconhecidoHIV | Crianças não infectadas pelo HIV | Crianças expostas ao HIVCamarões
-
University of MinnesotaRetiradoInfecções por HIV | HIV/AIDS | HIV | AUXILIA | Aids/problema de HIV | AIDS e InfecçõesEstados Unidos
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationConcluídoTeste de HIV do parceiro | Aconselhamento de casal HIV | Comunicação de casal | Incidência de HIVCamarões, República Dominicana, Geórgia, Índia
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... e outros colaboradoresRecrutamentoHIV | Teste de HIV | Vinculação ao cuidadoÁfrica do Sul
-
CDC FoundationGilead SciencesDesconhecidoProfilaxia pré-exposição ao HIV | Quimioprofilaxia HIVEstados Unidos
-
Erasmus Medical CenterAinda não está recrutandoInfecções por HIV | HIV | Infecção por HIV-1 | Infecção HIV IHolanda
-
Helios SaludViiV HealthcareDesconhecidoHIV | Infecção por HIV-1Argentina
-
National Taiwan UniversityRecrutamento
-
University of Maryland, BaltimoreRetiradoHIV | Transplante de rim | Reservatório de HIV | CCR5Estados Unidos
Ensaios clínicos em Observação
-
IRCCS Eugenio MedeaMassachusetts Institute of Technology; Politecnico di MilanoRecrutamento