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

Imperial College London

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: nevirapine; Drug: atazanavir/ritonavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00540137

Eudra-CT 2007-002405-47

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

NRTIs plus NNRTI arm

Active Comparator group

Description:

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

Treatment:

Drug: nevirapine

NRTIs plus PI arm

Active Comparator group

Description:

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

Treatment:

Drug: atazanavir/ritonavir