Trial record 4 of 59 for:
HIV AND "treatment naive" | Open Studies | HIV
The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Imperial College London.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Imperial College London
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00540137
First received: October 4, 2007
Last updated: May 25, 2010
Last verified: May 2010
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
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 2011 (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 |
| 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 | |
| Heart of England NHS Foundation Trust | Recruiting |
| Birmingham, United Kingdom | |
| Contact: Jessica Pugh 07791 502 758 jessica.pugh@heartofengland.nhs.uk | |
| Contact: Gerry Gilleran 0121 424 0644 gerry.gilleran@heartofengland.nhs.uk | |
| Principal Investigator: Stephen Taylor | |
| 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: | Alan Winston, 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 25, 2010 |
| 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 Acquired Immunodeficiency Syndrome Anti-HIV Agents HIV Protease Inhibitors Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Nevirapine Ritonavir Atazanavir Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013