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Clinical Trials/NCT00540137
NCT00540137
Completed
Phase 4

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

Imperial College London2 sites in 1 country21 target enrollmentJuly 2007
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ConditionsHIV Infections
Interventionsnevirapineatazanavir/ritonavir
Drugsnevirapineatazanavir/ritonavir

Overview

Phase
Phase 4
Intervention
nevirapine
Conditions
HIV Infections
Sponsor
Imperial College London
Enrollment
21
Locations
2
Primary Endpoint
To assess changes in simple reaction time as measured by a computerised test battery
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
December 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

NRTIs plus NNRTI arm

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

Intervention: nevirapine

NRTIs plus PI arm

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

Intervention: atazanavir/ritonavir

Outcomes

Primary Outcomes

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

Time Frame: over study period

Study Sites (2)

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