The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects
This study has been completed.
Sponsor:
Imperial College London
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
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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:
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 |
| 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
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
No publications provided
| 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 |
ClinicalTrials.gov processed this record on March 02, 2015