The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00540137
First received: October 4, 2007
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

The purpose of this study is to investigate the possibility of an association between changes in neurocognitive function, as measured by a computerised test battery, and the use of two different highly active antiretroviral therapy (HAART) regimens in treatment naïve HIV-1 infected subjects commencing antiretroviral therapy.


Condition Intervention Phase
HIV Infections
Drug: nevirapine
Drug: atazanavir/ritonavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Prospective Study Assessing Changes in Neurocognitive Function, Using a Computerised Test Battery, in Treatment Naïve HIV-1 Positive Subjects Commencing Two Different Antiretroviral Regimens

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • To assess changes in simple reaction time as measured by a computerised test battery [ Time Frame: over study period ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NRTIs plus NNRTI arm
nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone
Drug: nevirapine
400mg once daily
Active Comparator: NRTIs plus PI arm
atazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone
Drug: atazanavir/ritonavir
atazanavir 300 mg once daily ritonavir 100 mg once daily

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infected males or females
  • Signed informed consent
  • No previous antiretroviral treatment
  • Males with CD4+ lymphocyte count < 400 cells/ųL and females with CD4+ lymphocyte count < 250 cells/ųL
  • Susceptible to all currently licensed nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)

Exclusion Criteria:

  • Existing neurological disease
  • Hepatitis B or hepatitis C co-infection
  • Current history of major depression or psychosis
  • Recent head injury
  • Current alcohol abuse or drug dependence
  • Active opportunistic infection or significant co-morbidities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540137

Contacts
Contact: Ken Legg k.legg@imperial.ac.uk

Locations
United Kingdom
Heart of England NHS Foundation Trust Recruiting
Birmingham, United Kingdom
Contact: Jessica Pugh    07791 502 758    jessica.pugh@heartofengland.nhs.uk   
Contact: Gerry Gilleran    0121 424 0644    gerry.gilleran@heartofengland.nhs.uk   
Principal Investigator: Stephen Taylor         
St. Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact: Alan Winston, MBChB    +44 20 78861603    a.winston@imperial.ac.uk   
Contact: Ken Legg, BSc    +44 20 7886 1464    k.legg@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Boehringer Ingelheim
Investigators
Principal Investigator: Alan Winston Imperial College London
  More Information

No publications provided

Responsible Party: Alan Winston, Imperial College London
ClinicalTrials.gov Identifier: NCT00540137     History of Changes
Other Study ID Numbers: Eudra-CT 2007-002405-47
Study First Received: October 4, 2007
Last Updated: May 25, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Antiretroviral therapy
Neurocognitive function
Magnetic resonance spectroscopy
HIV disease
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Ritonavir
Atazanavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014