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

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ClinicalTrials.gov Identifier: NCT00540137
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : May 21, 2014
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Imperial College London

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: nevirapine Drug: atazanavir/ritonavir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To assess changes in simple reaction time as measured by a computerised test battery [ Time Frame: over study period ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540137


Locations
United Kingdom
Heart of England NHS Foundation Trust
Birmingham, United Kingdom
St. Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Boehringer Ingelheim
Investigators
Principal Investigator: Alan Winston Imperial College London
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00540137     History of Changes
Other Study ID Numbers: Eudra-CT 2007-002405-47
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2010

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir Sulfate
Nevirapine
HIV Protease Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers