The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects
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ClinicalTrials.gov Identifier: NCT00540137 |
Recruitment Status
:
Completed
First Posted
: October 5, 2007
Last Update Posted
: May 21, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: nevirapine Drug: atazanavir/ritonavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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
|
- To assess changes in simple reaction time as measured by a computerised test battery [ Time Frame: over study period ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540137
United Kingdom | |
Heart of England NHS Foundation Trust | |
Birmingham, United Kingdom | |
St. Mary's Hospital | |
London, United Kingdom, W2 1NY |
Principal Investigator: | Alan Winston | Imperial College London |
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00540137 History of Changes |
Other Study ID Numbers: |
Eudra-CT 2007-002405-47 |
First Posted: | October 5, 2007 Key Record Dates |
Last Update Posted: | May 21, 2014 |
Last Verified: | May 2010 |
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 |