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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00540137
First received: October 4, 2007
Last updated: May 20, 2014
Last verified: May 2010

October 4, 2007
May 20, 2014
July 2007
December 2012   (final data collection date for primary outcome measure)
To assess changes in simple reaction time as measured by a computerised test battery [ Time Frame: over study period ] [ Designated as safety issue: No ]
To assess changes in simple reaction time over study period as measured by a computerised test battery
Complete list of historical versions of study NCT00540137 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: nevirapine
    400mg once daily
  • Drug: atazanavir/ritonavir
    atazanavir 300 mg once daily ritonavir 100 mg once daily
  • Active Comparator: NRTIs plus NNRTI arm
    nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone
    Intervention: Drug: nevirapine
  • Active Comparator: NRTIs plus PI arm
    atazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone
    Intervention: Drug: atazanavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00540137
Eudra-CT 2007-002405-47
No
Imperial College London
Imperial College London
Boehringer Ingelheim
Principal Investigator: Alan Winston Imperial College London
Imperial College London
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP