Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa

NCT01367236

Last updated date
Study Location
Birmingham Heartlands Hospital:
Birmingham, , , United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV, Impaired Cognition
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- HIV-1 infected males or females

- signed informed consent

- no previous antiretroviral treatment since HIV diagnosis

- screening CD4+ lymphocyte count <= 350 cells/ųL

- susceptible to all currently licensed (Nucleoside Reverse Transcriptase Inhibitors) NRTIs, (Non-Nucleoside Reverse Transcriptase Inhibitors) NNRTIs and PIs based on HIV-1 genotypic resistance report

- CCR5-tropic HIV based on genotypic resistance testing*

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- • existing neurological disease


- hepatitis B or hepatitis C co-infection


- age under 18 years


- screening laboratory parameters > grade 2 (with the exception of cholesterol and
triglycerides)


- current history of major depression or psychosis


- recent head injury (past three months)


- current alcohol abuse or drug dependence


- active opportunistic infection or significant co-morbidities


- patients who are receiving other concomitant medication which are not permitted,
as listed in appendix 2


- female patients of child-bearing potential who:


- have a positive serum pregnancy test at screening or during the study


- are breast feeding


- are planning to become pregnant


- all participants unwilling to use a barrier method of contraception


- patients who in the opinion of the investigator are not candidates for inclusion
in the study

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HIV, Impaired CognitionChanges in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
NCT01367236
  1. Birmingham,
  2. Brighton,
  3. London:,
  4. London,
  5. London,
  6. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
Official Title  ICMJE A Randomised, Prospective Study, Assessing Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa.
Brief Summary

The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.

The study will compare anti-HIV therapy combinations which are currently in use.

The patients will not have had any previous treatment for their HIV infection.

Detailed Description

Impairment in neurocognitive(NC) function in HIV-infected subjects in the current anti-retroviraltreatment (cART) era has been associated with poor compliance with cART, reduced quality-of-life and increased mortality. Reported factors associated with the development of NC function impairment in HIV disease and risks associated with progression of such impairment include degree of immune suppression related to HIV infection, other chronic viral infections (such as chronic hepatitis C co-infection), age and central nervous system (CNS) antiretroviral drug exposure.

One modifiable factor which may be associated with the evolution of NC function impairment is the direct effect of cART on the central-nervous-system (CNS). Certain antiretroviral drugs such as zidovudine, lamivudine, abacavir, nevirapine, efavirenz and indinavir are known to achieve optimal exposure in the cerebro-spinal-fluid (CSF) whereas other drugs, such as the majority of the HIV-1 protease inhibitors penetrate less effectively. Studies to date suggest different cART regimens may have differing effects on NC performance. In the EuroSIDA study, the use of nucleoside-reverse-transcriptase inhibitors was found to specifically protect against the development of HIV related brain disease. More recently, in a small prospective study, ALTAIR, different effect on cerebral function was reported in subjects randomised to commence three different cART regimens.

The investigators propose, in a prospective, randomised study to assess the effects of two different antiretroviral regimens on NC function in HIV infected subjects commencing antiretroviral therapy for the first time.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • Impaired Cognition
Intervention  ICMJE
  • Drug: standard care
    • atazanavir 300 mg daily
    • ritonavir 100 mg daily
    • tenofovir 245 mg daily*
    • emtricitabine 200 mg daily*
  • Drug: novel treatment
    • darunavir 800 mg daily
    • ritonavir 100 mg daily
    • lamivudine 300 mg daily** and abacavir 600mgs daily**
    • maraviroc 150 mg once daily
Study Arms  ICMJE
  • Active Comparator: standard care

    treatment with:

    • atazanavir 300 mg daily
    • ritonavir 100 mg daily
    • tenofovir 245 mg daily*
    • emtricitabine 200 mg daily* * as the fixed dose combination Truvada?
    Intervention: Drug: standard care
  • Active Comparator: Novel therapeutic approach
    • darunavir 800 mg daily
    • ritonavir 100 mg daily
    • lamivudine 300 mg daily**
    • abacavir 600 mg daily**
    • maraviroc 150 mg once daily ** as the fixed dose combination Kivexa ?
    Intervention: Drug: novel treatment
Publications * Mora-Peris B, Bouliotis G, Ranjababu K, Clarke A, Post FA, Nelson M, Burgess L, Tiraboschi J, Khoo S, Taylor S, Ashby D, Winston A. Changes in cerebral function parameters with maraviroc-intensified antiretroviral therapy in treatment naive HIV-positive individuals. AIDS. 2018 May 15;32(8):1007-1015. doi: 10.1097/QAD.0000000000001786.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2011)
50
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-1 infected males or females
  • signed informed consent
  • no previous antiretroviral treatment since HIV diagnosis
  • screening CD4+ lymphocyte count <= 350 cells/?L
  • susceptible to all currently licensed (Nucleoside Reverse Transcriptase Inhibitors) NRTIs, (Non-Nucleoside Reverse Transcriptase Inhibitors) NNRTIs and PIs based on HIV-1 genotypic resistance report
  • CCR5-tropic HIV based on genotypic resistance testing*

Exclusion Criteria:

  • ? existing neurological disease

    • hepatitis B or hepatitis C co-infection
    • age under 18 years
    • screening laboratory parameters > grade 2 (with the exception of cholesterol and triglycerides)
    • current history of major depression or psychosis
    • recent head injury (past three months)
    • current alcohol abuse or drug dependence
    • active opportunistic infection or significant co-morbidities
    • patients who are receiving other concomitant medication which are not permitted, as listed in appendix 2
    • female patients of child-bearing potential who:

      • have a positive serum pregnancy test at screening or during the study
      • are breast feeding
      • are planning to become pregnant
    • all participants unwilling to use a barrier method of contraception
    • patients who in the opinion of the investigator are not candidates for inclusion in the study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01367236
Other Study ID Numbers  ICMJE 1733
2011-002656-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Alan WinstonImperial College London
PRS Account Imperial College London
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP