- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Gauteng
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Johannesburg, Gauteng, Afrique du Sud, 1862
- Soweto HVTN CRS
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Kwa Zulu Natal
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Durban, Kwa Zulu Natal, Afrique du Sud, 4013
- eThekwini CRS
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North West Province
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Klerksdorp, North West Province, Afrique du Sud, 2571
- Aurum Institute Klerksdorp CRS
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Western Cape
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Cape Town, Western Cape, Afrique du Sud, 7750
- Emavundleni CRS
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Port-au-Prince, Haïti, HT-6110
- Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
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San Juan, Porto Rico, 00935
- Maternal-Infant Studies Center (CEMI) CRS
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Maynas
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Iquitos, Maynas, Pérou, 1
- ACSA CRS
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Santo Domingo, République Dominicaine
- Unidad de Vacunas IDCP-COIN-DIGECITSS CRS
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- Alabama Vaccine CRS
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California
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San Francisco, California, États-Unis, 94143
- Bridge HIV CRS
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Georgia
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Decatur, Georgia, États-Unis, 30030
- The Hope Clinic of the Emory Vaccine Center CRS
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Illinois
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Chicago, Illinois, États-Unis, 60612
- UIC Project WISH CRS
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115-6110
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
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Boston, Massachusetts, États-Unis, 02215-4302
- Fenway Health Clinical Research Site CRS
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New York
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New York, New York, États-Unis, 10003
- NY Blood Ctr./Union Square CRS
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New York, New York, États-Unis, 10032-3732
- Columbia P&S CRS
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New York, New York, États-Unis, 10455
- NY Blood Ctr./Bronx CRS
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New York, New York, États-Unis, 14642
- University of Rochester Vaccines to Prevent HIV Infection CRS
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Penn Prevention CRS
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Tennessee
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Nashville, Tennessee, États-Unis, 37232-2582
- Vanderbilt Vaccine (VV) CRS
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Washington
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Seattle, Washington, États-Unis, 98109-1024
- Seattle Vaccine and Prevention CRS
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Participants infected with HIV-1
Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Measure plasma HIV-1 RNA levels and CD4+ T cell counts longitudinally
Délai: 8 years
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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.
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8 years
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Measure time to initiation of ART
Délai: 8 years
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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.
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8 years
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Measure time to HIV-1 related clinical events
Délai: 8 years
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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
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Proportion of individuals with plasma HIV-1 RNA level <50 copies/mL at 24 weeks after initiation of ART
Délai: 8 years
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons
Délai: 8 years
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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.
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8 years
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Occurrence of HIV/AIDS associated events, including death
Délai: 8 years
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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.
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8 years
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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
Délai: 24, 48, 96, and 144 weeks
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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.
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24, 48, 96, and 144 weeks
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Adherence information collected at 24, 48, 96, and 144 weeks following initiation of ART
Délai: 24, 48, 96, and 144 weeks
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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.
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24, 48, 96, and 144 weeks
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Side effects collected at 24, 48, 96, and 144 weeks following initiation of ART
Délai: 24, 48, 96, and 144 weeks
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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.
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24, 48, 96, and 144 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Magdalena Sobieszcyk, Columbia University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HVTN 802
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Infections à VIH
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Icahn School of Medicine at Mount SinaiIRRASRecrutementHémorragie intraventriculaire (HIV)États-Unis
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Yale UniversityComplétéPrématurité | Nourrissons de très faible poids à la naissance | Hémorragie intraventriculaire (HIV) | Saignement dans le cerveauÉtats-Unis
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West Virginia UniversityInscription sur invitationInfection de la peau et des tissus mous | Infection gastro-intestinale | Infection pulmonaire | Infection des os et des articulations | Infection endovasculaire | Infection génito-urinaireÉtats-Unis
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Taipei Medical University WanFang HospitalInconnue
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Ondine Biomedical Inc.ComplétéInfection du site opératoire | Infection nosocomiale | Infection associée aux soins de santéÉtats-Unis
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Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
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Angela BiancoStryker NordicRésiliéCésarienne | Infection du site opératoire | Infection nosocomialeÉtats-Unis
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Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... et autres collaborateursRecrutementInfection prothétique-articulaire | Infection de la hanche | Infection; Genou, ArticulationPays-Bas
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Cairo UniversityRecrutementInfection postopératoire | Complications de la césarienne | Infection vaginaleEgypte
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Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemComplétéInfection du site opératoire | Infection superficielle du site opératoire | Infection profonde du site chirurgical | Infection du site chirurgical d'un organe/de l'espaceÉtats-Unis