Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa (CogUK)
A Randomised, Prospective Study, Assessing Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa.
The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.
The study will compare anti-HIV therapy combinations which are currently in use.
The patients will not have had any previous treatment for their HIV infection.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Impairment in neurocognitive(NC) function in HIV-infected subjects in the current anti-retroviraltreatment (cART) era has been associated with poor compliance with cART, reduced quality-of-life and increased mortality. Reported factors associated with the development of NC function impairment in HIV disease and risks associated with progression of such impairment include degree of immune suppression related to HIV infection, other chronic viral infections (such as chronic hepatitis C co-infection), age and central nervous system (CNS) antiretroviral drug exposure.
One modifiable factor which may be associated with the evolution of NC function impairment is the direct effect of cART on the central-nervous-system (CNS). Certain antiretroviral drugs such as zidovudine, lamivudine, abacavir, nevirapine, efavirenz and indinavir are known to achieve optimal exposure in the cerebro-spinal-fluid (CSF) whereas other drugs, such as the majority of the HIV-1 protease inhibitors penetrate less effectively. Studies to date suggest different cART regimens may have differing effects on NC performance. In the EuroSIDA study, the use of nucleoside-reverse-transcriptase inhibitors was found to specifically protect against the development of HIV related brain disease. More recently, in a small prospective study, ALTAIR, different effect on cerebral function was reported in subjects randomised to commence three different cART regimens.
The investigators propose, in a prospective, randomised study to assess the effects of two different antiretroviral regimens on NC function in HIV infected subjects commencing antiretroviral therapy for the first time.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Birmingham, Regno Unito
- Birmingham Heartlands Hospital:
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Brighton, Regno Unito, BN1 9RE
- Brighton and Sussex University Hospital NHS Trust:
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London, Regno Unito
- St. Thomas' Hospital
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London, Regno Unito, SE5 9RJ
- Kings College Hospital
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London, Regno Unito, SW10 9NH
- Chelsea and Westminster Hospital NHS Trust
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London:, Regno Unito, W2 1NY
- St. Mary's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- HIV-1 infected males or females
- signed informed consent
- no previous antiretroviral treatment since HIV diagnosis
- screening CD4+ lymphocyte count <= 350 cells/ųL
- susceptible to all currently licensed (Nucleoside Reverse Transcriptase Inhibitors) NRTIs, (Non-Nucleoside Reverse Transcriptase Inhibitors) NNRTIs and PIs based on HIV-1 genotypic resistance report
- CCR5-tropic HIV based on genotypic resistance testing*
Exclusion Criteria:
• existing neurological disease
- hepatitis B or hepatitis C co-infection
- age under 18 years
- screening laboratory parameters > grade 2 (with the exception of cholesterol and triglycerides)
- current history of major depression or psychosis
- recent head injury (past three months)
- current alcohol abuse or drug dependence
- active opportunistic infection or significant co-morbidities
- patients who are receiving other concomitant medication which are not permitted, as listed in appendix 2
female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening or during the study
- are breast feeding
- are planning to become pregnant
- all participants unwilling to use a barrier method of contraception
- patients who in the opinion of the investigator are not candidates for inclusion in the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: standard care
treatment with:
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Comparatore attivo: Novel therapeutic approach
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Cognitive Function, Global Cognitive Score (Z-score)
Lasso di tempo: 24 weeks, 48 weeks
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When commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown. The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period. Score increase means improved performance of cognitive function |
24 weeks, 48 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Brain Function, Absolute Change Over 48 Weeks of N-acetyl Aspartate/Creatinine Ratio
Lasso di tempo: 48 weeks
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The study team will assess the brain functions at each visit.
The results of the MRI scans will be compared, changes in N-acetyl aspartate/creatinine ratio over 48 weeks.
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48 weeks
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Alan Winston, Imperial College London
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1733
- 2011-002656-14 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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