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

This study has been completed.

Sponsor:

Collaborator:

Boehringer Ingelheim

Information provided by (Responsible Party):

Imperial College London

ClinicalTrials.gov Identifier:

NCT00540137

First received: October 4, 2007

Last updated: May 20, 2014

Last verified: May 2010

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: HIV/AIDS

Drug Information available for: Nevirapine Ritonavir Atazanavir 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 ]


Enrollment:	21
Study Start Date:	July 2007
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: NRTIs plus NNRTI arm nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone	Drug: nevirapine 400mg once daily
Active Comparator: NRTIs plus PI arm 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 (Child, Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United Kingdom
Heart of England NHS Foundation Trust
Birmingham, United Kingdom
St. Mary's Hospital
London, United Kingdom, W2 1NY

Sponsors and Collaborators

Imperial College London

Boehringer Ingelheim

Investigators


Principal Investigator:	Alan Winston	Imperial College London

More Information


Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00540137 History of Changes
Other Study ID Numbers:	Eudra-CT 2007-002405-47
Study First Received:	October 4, 2007
Last Updated:	May 20, 2014
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:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate Nevirapine HIV Protease Inhibitors	Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on September 26, 2016

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