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

This study is currently recruiting participants.

Verified by Imperial College London, September 2009

First Received: October 4, 2007 Last Updated: September 22, 2009 History of Changes

Sponsor:	Imperial College London
Collaborator:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00540137

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: nevirapine Drug: atazanavir/ritonavir	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Nevirapine Ritonavir BMS 232632 Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

To assess changes in simple reaction time as measured by a computerised test battery [ Time Frame: over study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2007
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NRTIs plus NNRTI arm: Active Comparator nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone	Drug: nevirapine 400mg once daily
NRTIs plus PI arm: Active Comparator atazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone	Drug: atazanavir/ritonavir atazanavir 300 mg once daily ritonavir 100 mg once daily

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540137

Contacts

Contact: Ken Legg

k.legg@imperial.ac.uk

Locations

United Kingdom
St. Mary's Hospital	Recruiting
London, United Kingdom, W2 1NY
Contact: Alan Winston, MBChB +44 20 78861603 a.winston@imperial.ac.uk
Contact: Ken Legg, BSc +44 20 7886 1464 k.legg@imperial.ac.uk

Sponsors and Collaborators

Imperial College London

Boehringer Ingelheim Pharmaceuticals

Investigators

Principal Investigator:

Alan Winston

Imperial College London

More Information

No publications provided

Responsible Party:	Imperial College London ( Alan Winston )
Study ID Numbers:	Eudra-CT 2007-002405-47
Study First Received:	October 4, 2007
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00540137 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:

Antiretroviral therapy
Neurocognitive function
Magnetic resonance spectroscopy
HIV disease
Treatment Naive

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases

Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Nevirapine
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010