Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects

14 aprile 2020 aggiornato da: GlaxoSmithKline

Optimizing the Quality of Samples Used for the Evaluation of Cell-mediated Immune (CMI) Responses in Antiretroviral Therapy (ART)-naïve Human Deficiency Virus Type 1 (HIV-1)-Infected Subjects

The purpose of this study is to investigate a combined set of parameters deemed to impact the quality of CMI analyses in terms of the proportion of viable lymphocytes in antiretroviral therapy-naïve HIV-1 infected subjects.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study will address the respective and combined impact of (i) timing between blood collection and peripheral blood mononuclear cells (PBMC) processing ["time-to-process"] and (ii) timing of PBMC resting before stimulation ["resting -time"].

Tipo di studio

Interventistico

Iscrizione (Effettivo)

22

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Gent, Belgio, 9000
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

  • Subjects who the Investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject prior to any study procedure.
  • A male or female between and including 18 and 55 years of age at the time of enrollment.
  • Confirmed HIV-1 infection.
  • ART-naïve and not eligible for ART treatment as per established guidelines. Subjects must never have received ART after HIV diagnosis, including lamivudine used for chronic hepatitis B infection. The exception to this is short-term ART for prevention of mother-to-child transmission (PMTCT) which must have been completed at least 360 days prior to enrollment.
  • Viral load level between and including 2,000 and 100,000 copies/mL at screening.
  • CD4+ T cell count >500 cells/mm3 at screening.

  • If the subject is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal. Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test at screening, and
    • has agreed to continue adequate contraception during the entire study period.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:

  • Infection with HIV-2. This includes subjects with dual infection with HIV-1/HIV-2.
  • Planned use of any hematotoxic product during the study period.
  • Planned use of any investigational or non-registered product during the study period.
  • Acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination, serology and/or medical history at screening.
  • Grade 3 or grade 4 laboratory abnormalities, as defined by Division of AIDS (DAIDS) grading table, at screening.
  • Any condition which, in the opinion of the Investigator, could compromise the subject's adherence to the study protocol.
  • Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the Sample Collection Visit (Visit 2). Vaccine can be administered as after sampling in Visit 2.
  • Pregnant or lactating female.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: HIV-1 Group
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
Procedura: Blood sample collection
Blood samples will be collected in all subjects at two time points, at the Screening Visit (Day 0) and at the Sample Collection Visit (Day 15)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Lymphocytes Viability Prediction (LOGIT Transformed) in CMI Samples Post-overnight Incubation Time Before Intracellular Cytokine Staining (ICS): "Intercept" Parameter Estimate of the Prediction Model - Condition "None" Resting Time Not Included
Lasso di tempo: At Day 15 (sample collection visit)
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h ["none" resting time not included]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10^P/(1 + 10^P)*100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + a*a*TP*TP + b*b*RT*RT. Where "intercept", "TP", "RT", "TP*RT", "TP *TP", "RT*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting the intercept i.e. expected mean value of Prediction when "TP" and "RT" = 0. The optimum of this Design of Experiment is presented in outcome 4.
At Day 15 (sample collection visit)
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Time to Process and Resting Time Parameter Estimates of the Prediction Model - Condition "None" Resting Time Not Included
Lasso di tempo: At Day 15 (sample collection visit)
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h ["none" resting time not included]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + a*a*TP*TP + b*b*RT*RT. Where "intercept", "TP", "RT", "TP*RT", "TP *TP", "RT*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting "TP" and "RT" estimates expressed as log(hours). The optimum of this Design of Experiment (DOE) is presented in outcome 4.
At Day 15 (sample collection visit)
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT, TP*TP and RT*RT Parameter Estimates of the Prediction Model - Condition "None" Resting Time Not Included
Lasso di tempo: At Day 15 (sample collection visit)
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h ["none" resting time not included]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + a*a*TP*TP + b*b*RT*RT. Where "intercept", "TP", "RT", "TP*RT", "TP *TP", "RT*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting TP*RT, TP*TP and RT*RT estimates expressed as log(hours^2). The optimum of this DOE is presented in outcome 4.
At Day 15 (sample collection visit)
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Optimum Mean Cell Viability Estimate by the Prediction Model - Condition "None" Resting Time Not Included
Lasso di tempo: At Day 15 (sample collection visit)
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h ["none" resting time not included]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + a*a*TP*TP + b*b*RT*RT. Where "intercept", "TP", "RT", "TP*RT", "TP *TP", "RT*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. The optimum predicted mean cell viability of this Design of Experiment is presented in this outcome and expressed as percentage.
At Day 15 (sample collection visit)
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: "Intercept" Parameter Estimate of the Prediction Model - Condition "None" Resting Time Included
Lasso di tempo: At Day 15 (sample collection visit)
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + + b*b*RT*RT. Where "intercept", "TP", "RT", "TP*RT", "TP *TP", "RT*RT" are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And "a" and "b" are parameters (hour) corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting the intercept i.e. expected mean value of Prediction when "TP" and "RT" = 0. The optimum of this Design of Experiment is presented in outcome 8.
At Day 15 (sample collection visit)
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Time to Process and Resting Time Parameter Estimates of the Prediction Model - Condition "None" Resting Time Included
Lasso di tempo: At Day 15 (sample collection visit)
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + + b*b*RT*RT. Where "intercept", "TP", "RT", "TP*RT", "TP *TP", "RT*RT" are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And "a" and "b" are parameters (hour) corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting "TP" and "RT" estimates expressed as log(hours). The optimum of this Design of Experiment (DOE) is presented in outcome 8.
At Day 15 (sample collection visit)
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT and RT*RT Parameter Estimates of the Prediction Model - Condition "None" Resting Time Included
Lasso di tempo: At Day 15 (sample collection visit)
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + + b*b*RT*RT. Where "intercept", "TP", "RT", "TP*RT", "TP *TP", "RT*RT" are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And "a" and "b" are parameters (hour) corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting TP*RT and RT*RT estimates expressed as log(hours^2). The optimum of this DOE is presented in outcome 8.
At Day 15 (sample collection visit)
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Optimum Mean Cell Viability Estimates by the Prediction Model -Condition "None" Resting Time Included.
Lasso di tempo: At Day 15 (sample collection visit)
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + + b*b*RT*RT. Where "intercept", "TP", "RT", "TP*RT", "TP *TP", "RT*RT" are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And "a" and "b" are parameters (hour) corresponding respectively to the "TP" and the "RT" where the prediction has to be done. The optimum predicted mean cell viability of this Design of Experiment is presented in this outcome and expressed as percentage.
At Day 15 (sample collection visit)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Viable Lymphocytes in the CMI Samples, Post-overnight Incubation (Classic) Before ICS and Post-6 Hour Incubation Before ICS
Lasso di tempo: A Day 15 (sample collection visit)
The percentage of viable lymphocytes was determined by Forward Scatter/Side Scatter (FSC/SSC) and LIVE/DEAD gating during flow cytometry analysis for each incubation of time-to-time process (TP) = 2h, 7h and 24 h and resting time (RT) = 18h for the comparison of resting time = 18h and classic incubation time versus resting time = 18h and post-6h incubation time.
A Day 15 (sample collection visit)
Magnitude of HIV-1 RT Specific Cluster of Differentiation 40 Ligand (CD40L+) CD4+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
Lasso di tempo: At Day 15 (sample collection visit)
Data were collected but could not be reported as data were below level of detection.
At Day 15 (sample collection visit)
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
Lasso di tempo: At Day 15 (sample collection visit)
HIV-RT specific responses of CD8+ T cells expressing at least one cytokine, among: Interleukin-2 (IL-2), Interferon-gamma (IFN-g) and Tumor necrosis factor alpha (TNF-a),after stimulation with HIV-1 peptide pools for time-to-process (TP) (2, 7, 24 hours) and resting time (RT) (0,2,6,18 hours) post-overnight ICS and for time-to-process (7 hours) and resting time (18 hours) post 6 hours ICS.
At Day 15 (sample collection visit)
Number of Subjects With Serious Adverse Events (SAEs)
Lasso di tempo: During the whole study period (From Day 0 to Day 15)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitali-zation or prolongation of hospitalization or result in disability/incapacity.
During the whole study period (From Day 0 to Day 15)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 giugno 2012

Completamento primario (Effettivo)

30 ottobre 2012

Completamento dello studio (Effettivo)

30 ottobre 2012

Date di iscrizione allo studio

Primo inviato

31 maggio 2012

Primo inviato che soddisfa i criteri di controllo qualità

31 maggio 2012

Primo Inserito (Stima)

4 giugno 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 116329

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

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 AIDS

Prove cliniche su Blood sample collection

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in United Kingdom

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi