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CompletedNCT00540137Updated May 21, 2014

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

A Phase 4 interventional study of nevirapine and atazanavir/ritonavir in HIV Infections, sponsored by Imperial College London. Completed at 2 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2014-05-21.

Sponsored by Imperial College London · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • Antiretroviral therapy
  • Neurocognitive function
  • Magnetic resonance spectroscopy
  • HIV disease
  • Treatment Naive
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 21 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

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Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    NRTIs plus NNRTI arm

    nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone

    Drug: nevirapine

  • Active comparator
    NRTIs plus PI arm

    atazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone

    Drug: atazanavir/ritonavir

Interventions

  • Drugnevirapine

    400mg once daily

  • Drugatazanavir/ritonavir

    atazanavir 300 mg once daily ritonavir 100 mg once daily

06

What researchers measure

Primary outcomes

  1. To assess changes in simple reaction time as measured by a computerised test battery

    Time frame: over study period

07

Study locations

2 sites
  • Heart of England NHS Foundation Trust
    Birmingham, United Kingdom
  • St. Mary's Hospital
    London, W2 1NY, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00540137
Lead sponsor
Imperial College London
Collaborators
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 5, 2007
Start date
Jul 2007
Primary completion
Dec 2012
Completion
Dec 2012
Last update
May 21, 2014

Study contacts

Alan Winston
principal investigator · Imperial College London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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