NCT00540137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2010

Enrollment Period

5.4 years

First QC Date

October 4, 2007

Last Update Submit

May 20, 2014

Conditions

HIV Infections

Keywords

Antiretroviral therapyNeurocognitive functionMagnetic resonance spectroscopyHIV diseaseTreatment Naive

Outcome Measures

Primary Outcomes (1)

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

    over study period

Study Arms (2)

NRTIs plus NNRTI arm

ACTIVE COMPARATOR

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

Drug: nevirapine

NRTIs plus PI arm

ACTIVE COMPARATOR

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

Drug: atazanavir/ritonavir

Interventions

nevirapineDRUG

400mg once daily

NRTIs plus NNRTI arm
atazanavir/ritonavirDRUG

atazanavir 300 mg once daily ritonavir 100 mg once daily

NRTIs plus PI arm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Heart of England NHS Foundation Trust

Birmingham, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Nevirapineatazanavir, ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alan Winston

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 5, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 21, 2014

Record last verified: 2010-05

Locations

GB(2)