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

Imperial College London21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

nevirapineDRUG

400mg once daily

atazanavir/ritonavirDRUG

atazanavir 300 mg once daily ritonavir 100 mg once daily

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (2)

Heart of England NHS Foundation Trust

Birmingham, United Kingdom

St. Mary's Hospital

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: over study period

Data from ClinicalTrials.gov

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