HIV InfectionsPhase 4NCT00540137
The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects
A Phase 4 study testing nevirapine and atazanavir/ritonavir in people with HIV Infections, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- nevirapine and atazanavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2007to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Heart of England NHS Foundation Trust
Birmingham
St. Mary's Hospital
London, W2 1NY
About this study
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
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.
- Conditions
- HIV Infections
- Being tested
- nevirapine, atazanavir/ritonavir
- Keywords
- Antiretroviral therapy, Neurocognitive function, Magnetic resonance spectroscopy, HIV disease, Treatment Naive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nevirapineDrug
400mg once daily
atazanavir/ritonavirDrug
atazanavir 300 mg once daily ritonavir 100 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| NRTIs plus NNRTI arm | Active comparator | nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone Receives: Drug: nevirapine |
| NRTIs plus PI arm | Active comparator | atazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone Receives: Drug: atazanavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess changes in simple reaction time as measured by a computerised test battery
Measured: over study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Alan Winston, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540137
- Sponsor's protocol ID
- Eudra-CT 2007-002405-47
- Status last verified
- May 2010
- First submitted
- 4 Oct 2007
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00540137
- Acronym / sponsor ID
- Eudra-CT 2007-002405-47
- Conditions
- HIV Infections
- Keywords
- Antiretroviral therapy, Neurocognitive function, Magnetic resonance spectroscopy, HIV disease, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jul 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NRTIs plus NNRTI arm | Active comparator | Drug: nevirapinenevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone |
| NRTIs plus PI arm | Active comparator | Drug: atazanavir/ritonaviratazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nevirapine400mg once daily | Drug | NRTIs plus NNRTI arm |
| atazanavir/ritonaviratazanavir 300 mg once daily ritonavir 100 mg once daily | Drug | NRTIs plus PI arm |
Primary outcome
To assess changes in simple reaction time as measured by a computerised test battery
Time frame: over study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Winston principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nevirapine and atazanavir/ritonavir in people with HIV Infections, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess changes in simple reaction time as measured by a computerised test battery (time frame: over study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.