- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02043769
Pediatric Enhanced Surveillance Study (PESS)
Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa
Panoramica dello studio
Stato
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Amathole
-
East London, Amathole, Sud Africa
- Cecilia Makiwane Hospital
-
East London, Amathole, Sud Africa
- Frere Hospital
-
-
Nelson Mandela Bay
-
Port Elizabeth, Nelson Mandela Bay, Sud Africa
- Dora Ngiza Hospital
-
Port Elizabeth, Nelson Mandela Bay, Sud Africa
- Kwazakhele Community Health Center
-
Port Elizabeth, Nelson Mandela Bay, Sud Africa
- Motherwell Community Health Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Human immunodeficiency virus (HIV)-infected children accessing HIV care and treatment services in the Eastern Cape of South Africa are the population of interest for the overall study.
- Records review: All children with a record of care at the study facilities in the Wellness or antiretroviral (ART) clinic will form the study population.
- Prospective cohort: ART-naïve children receiving care at participating sites who have reached eligibility for ART and consent to participate will form the study population. The sample for the study will be a subset of all children enrolled and receiving care at these public health care facilities.
Descrizione
Inclusion Criteria:
- The child is eligible for antiretroviral therapy (ART) initiation based on the South African Pediatric HIV guidelines.
- The child has documentation of being HIV-infected by a positive HIV-Deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), detectable HIV ribonucleic acid (RNA) viral load or a positive HIV antibody test (>18 months of age).
- The child has no prior history of treatment with ART other than prophylaxis for preventing mother to child transmission (PMTCT) (may be initiating ART on day of enrollment in study).
- The child is between 1 month and 12 years of age.
- The parent or legal guardian provides written consent for participation.
- The child provides assent for participation based on South African guidance for minors.
Exclusion Criteria:
- Any subject not meeting all of the above inclusion criteria will not be eligible for the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
---|
Prospective Cohort
The prospective cohort surveillance will be built upon and support the routine clinical care, visit schedule and monitoring system at each study site. Eligible HIV-infected ART naïve children who are accessing care at study sites will be recruited sequentially for study enrollment. Children enrolled in the surveillance study will attend study visits co-scheduled to coincide with routine clinical visits. Study nurses will:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Proportion of children alive and in care at 12 and 24 months after treatment initiation
Lasso di tempo: Up to 24 months
|
We will measure the proportion of children alive and in care at 12 and 24 months after treatment initiation amount prospective cohort participants through routine clinical and study visits.
|
Up to 24 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services
Lasso di tempo: Up to 24 months
|
We will describe the proportion of the children enrolled in HIV care and treatment services at the study facilities who start treatment and are retained in care for 6, 12, 24, 36 and 48 months by reviewing clinical records at each facility.
|
Up to 24 months
|
Proportion of children lost to follow-up
Lasso di tempo: Up to 24 months
|
We will describe the proportion of children lost to follow-up after enrollment in care and in those starting treatment by reviewing clinical records of study participants.
|
Up to 24 months
|
Proportion of children with documented deaths
Lasso di tempo: Up to 24 months
|
We will describe proportion of children with documented deaths and causes of deaths and time to death (from enrollment) by reviewing clinical records of participants.
|
Up to 24 months
|
Proportion of children who are virologically suppressed
Lasso di tempo: Up to 24 months
|
We will measure the proportion of children who are virologically suppressed (< 400 copies/mL, per South African National Guidelines) at 12 and 24* months after treatment initiation in the prospective cohort through routine clinical and study visits.
|
Up to 24 months
|
Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts
Lasso di tempo: Up to 24 months
|
We will measure the proportion of children, aged 2 to 5 years, on ART with CD4% <10% at 12, 24* months after treatment initiation and children older than 5 years on ART with CD4 count of < 100 at 12, 24 months after treatment initiation.
These outcomes will be measured in participants of the prospective cohort who will give additional blood samples during routine clinical care.
|
Up to 24 months
|
Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease
Lasso di tempo: Up to 24 months
|
We will measure the proportion of children on ART progressing to WHO Stage 4 disease at 12 and 24 months after treatment initiation in the prospective cohort.
|
Up to 24 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Elaine Abrams, MD, ICAP-NY, Columbia University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Malattie del sistema immunitario
- Malattie da virus lenti
- Infezioni da HIV
- Sindrome da immunodeficienza acquisita
- Sindromi da deficit immunologico
Altri numeri di identificazione dello studio
- AAAI1736
- U2GPS001537 (Sovvenzione/contratto NIH degli Stati Uniti)
- U262PS223540 (Altro numero di sovvenzione/finanziamento: MCAP)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Virus dell'immunodeficienza umana (HIV)
-
RTI InternationalCenters for Disease Control and PreventionCompletatoVirus dell'immunodeficienza umana (HIV) PositivoStati Uniti
-
AbbVieCompletatoInfezione da HIV | HIV-1 | Virus dell'immunodeficienza umana (HIV)Stati Uniti, Australia, Canada, Porto Rico
-
Auritec PharmaceuticalsEunice Kennedy Shriver National Institute of Child Health and Human Development... e altri collaboratoriCompletatoProfilassi del virus dell'immunodeficienza umana (HIV).Stati Uniti
-
University of MiamiCompletato
-
University of AarhusAarhus University HospitalCompletatoHIV | Virus del papilloma umanoDanimarca
-
Janssen-Cilag International NVCompletatoInfezioni da virus dell'immunodeficienza umana (HIV). | Virus della sindrome da immunodeficienza acquisita (AIDS).Francia, Regno Unito, Belgio, Germania, Spagna, Svizzera, Danimarca, Israele, Austria, Polonia, Ungheria, Svezia, Irlanda
-
Energex Systems, Inc.SconosciutoInfezioni da HIV | HIVStati Uniti
-
Gilead SciencesCompletatoHIV | Virus dell'immunodeficienza umana | HIV-1Stati Uniti, Porto Rico
-
Merck Sharp & Dohme LLCRitiratoInfezioni da virus dell'immunodeficienza umana (HIV).
-
Bristol-Myers SquibbCompletatoInfezioni da virus dell'immunodeficienza umana (HIV).Spagna