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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: Boehringer Ingelheim
• Treatments: Atazanavir Sulfate; Nevirapine; Ritonavir

Criteria

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