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

This study has been completed.
Boehringer Ingelheim
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: October 4, 2007
Last updated: May 20, 2014
Last verified: May 2010

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 ]

Enrollment: 21
Study Start Date: July 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00540137

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
Principal Investigator: Alan Winston Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London Identifier: NCT00540137     History of Changes
Other Study ID Numbers: Eudra-CT 2007-002405-47
Study First Received: October 4, 2007
Last Updated: May 20, 2014
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 processed this record on March 31, 2015