search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
nevirapine
atazanavir/ritonavir
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antiretroviral therapy, Neurocognitive function, Magnetic resonance spectroscopy, HIV disease, Treatment Naive

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart of England NHS Foundation Trust
  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

NRTIs plus NNRTI arm

NRTIs plus PI arm

Arm Description

nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone

atazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone

Outcomes

Primary Outcome Measures

To assess changes in simple reaction time as measured by a computerised test battery

Secondary Outcome Measures

Full Information

First Posted
October 4, 2007
Last Updated
May 20, 2014
Sponsor
Imperial College London
Collaborators
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00540137
Brief Title
The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Boehringer Ingelheim

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Antiretroviral therapy, Neurocognitive function, Magnetic resonance spectroscopy, HIV disease, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NRTIs plus NNRTI arm
Arm Type
Active Comparator
Arm Description
nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone
Arm Title
NRTIs plus PI arm
Arm Type
Active Comparator
Arm Description
atazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone
Intervention Type
Drug
Intervention Name(s)
nevirapine
Intervention Description
400mg once daily
Intervention Type
Drug
Intervention Name(s)
atazanavir/ritonavir
Intervention Description
atazanavir 300 mg once daily ritonavir 100 mg once daily
Primary Outcome Measure Information:
Title
To assess changes in simple reaction time as measured by a computerised test battery
Time Frame
over study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Winston
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart of England NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs