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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00540137

Enrollment

Registered

2007-10-05

Start date

2007-07-31

Completion date

2012-12-31

Last updated

2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Antiretroviral therapy, Neurocognitive function, Magnetic resonance spectroscopy, HIV disease, Treatment Naive

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.

Interventions

DRUGnevirapine

400mg once daily

DRUGatazanavir/ritonavir

atazanavir 300 mg once daily ritonavir 100 mg once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess changes in simple reaction time as measured by a computerised test battery	over study period

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026