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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00540137
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : May 21, 2014
Boehringer Ingelheim
Information provided by (Responsible Party):
Imperial College London

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

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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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00540137

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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
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Principal Investigator: Alan Winston Imperial College London
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Responsible Party: Imperial College London Identifier: NCT00540137    
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:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
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