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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NRTIs plus NNRTI arm

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

Group Type ACTIVE_COMPARATOR

nevirapine

Intervention Type DRUG

400mg once daily

NRTIs plus PI arm

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

Group Type ACTIVE_COMPARATOR

atazanavir/ritonavir

Intervention Type DRUG

atazanavir 300 mg once daily ritonavir 100 mg once daily

Interventions

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nevirapine

400mg once daily

Intervention Type DRUG

atazanavir/ritonavir

atazanavir 300 mg once daily ritonavir 100 mg once daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No