search
Back to results

Statin Adjunct Therapy Among ART-treated Adults in Sub-Saharan Africa: Atorvastatin and Rosuvastatin Equivalence Trial (STAR)

Primary Purpose

HIV Infection

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ART, Atorvastatin
ART, Rosuvastatin
ART, No statin
Healthy-HIV-negative
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring adults, antiretroviral therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • HIV-positive individuals 18 years and older, that have initiated three first-line drug highly active antiretroviral therapy within three months within the Infectious Diseases Institute HIV treatment cohort
  • Individuals that provide written informed consent to participate in the clinical trial

Exclusion Criteria:

Individuals with dyslipidemia and eligible to receive or already receiving statin therapy

  • Pregnant or lactating mothers
  • Individuals with another active or controlled inflammatory condition
  • Individuals with deranged liver function tests 3 fold and above

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    ART-Atorvastatin adjunct therapy

    ART-Rosuvastatin adjunct therapy

    ART-without statin adjunct therapy

    Healthy-HIV-negative

    Arm Description

    ART, atorvastatin

    ART, rosuvastatin

    ART, no statin

    Age-matched HIV-negative, healthy volunteers from the same community

    Outcomes

    Primary Outcome Measures

    Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05)
    measured by percentage of HLADR+CD38+T-cells

    Secondary Outcome Measures

    Similar rate of change of immune aging markers, between ART-treated adults with and without statin (atorvastatin and rosuvastatin) adjunct therapy arms (P-value<0.05)
    Measured by Percentage of CD4+ and CD8+ naive T-cells or percentage of expressing Ki67 T-cells or percentage of low CFSE+T-cells or increase in percentage of CD28-/CD57+ T-cells or percentage of individuals with low host responses to influenza vaccine among HIV-infected adults at ART initiation
    Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05)
    Measured by levels of IL6 in pg/ml, hsCRP in pg/ml, d-dimers in pg/ml, IFABP in pg/ml, and LPS in pg/ml
    Biological pathways affected by atorvastatin and rosuvastatin
    number of genes down-regulated by either atorvastatin or rosuvastatin

    Full Information

    First Posted
    January 10, 2017
    Last Updated
    January 26, 2017
    Sponsor
    Makerere University
    Collaborators
    University of Oxford, Case Western Reserve University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03037372
    Brief Title
    Statin Adjunct Therapy Among ART-treated Adults in Sub-Saharan Africa: Atorvastatin and Rosuvastatin Equivalence Trial
    Acronym
    STAR
    Official Title
    Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa: Equivalence of Atorvastatin and Rosuvastatin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Makerere University
    Collaborators
    University of Oxford, Case Western Reserve University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will determine whether 36 months of daily atorvastatin or rosuvastatin have equivalent effects in reduction of immune activation, inflammation and immune aging, when given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort
    Detailed Description
    This is a randomized, open-label trial

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection
    Keywords
    adults, antiretroviral therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    320 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ART-Atorvastatin adjunct therapy
    Arm Type
    Experimental
    Arm Description
    ART, atorvastatin
    Arm Title
    ART-Rosuvastatin adjunct therapy
    Arm Type
    Experimental
    Arm Description
    ART, rosuvastatin
    Arm Title
    ART-without statin adjunct therapy
    Arm Type
    Experimental
    Arm Description
    ART, no statin
    Arm Title
    Healthy-HIV-negative
    Arm Type
    Experimental
    Arm Description
    Age-matched HIV-negative, healthy volunteers from the same community
    Intervention Type
    Drug
    Intervention Name(s)
    ART, Atorvastatin
    Other Intervention Name(s)
    Atovastatin adjunct therapy
    Intervention Description
    ART, Atorvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    ART, Rosuvastatin
    Other Intervention Name(s)
    Rosuvastatin adjunct therapy
    Intervention Description
    ART, Rosuvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    ART, No statin
    Other Intervention Name(s)
    No statin adjunct therapy
    Intervention Description
    ART, No statin
    Intervention Type
    Drug
    Intervention Name(s)
    Healthy-HIV-negative
    Other Intervention Name(s)
    HIV-negative controls
    Intervention Description
    Age-matched, Healthy HIV-negative
    Primary Outcome Measure Information:
    Title
    Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05)
    Description
    measured by percentage of HLADR+CD38+T-cells
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Similar rate of change of immune aging markers, between ART-treated adults with and without statin (atorvastatin and rosuvastatin) adjunct therapy arms (P-value<0.05)
    Description
    Measured by Percentage of CD4+ and CD8+ naive T-cells or percentage of expressing Ki67 T-cells or percentage of low CFSE+T-cells or increase in percentage of CD28-/CD57+ T-cells or percentage of individuals with low host responses to influenza vaccine among HIV-infected adults at ART initiation
    Time Frame
    36 months
    Title
    Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05)
    Description
    Measured by levels of IL6 in pg/ml, hsCRP in pg/ml, d-dimers in pg/ml, IFABP in pg/ml, and LPS in pg/ml
    Time Frame
    36 months
    Title
    Biological pathways affected by atorvastatin and rosuvastatin
    Description
    number of genes down-regulated by either atorvastatin or rosuvastatin
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: HIV-positive individuals 18 years and older, that have initiated three first-line drug highly active antiretroviral therapy within three months within the Infectious Diseases Institute HIV treatment cohort Individuals that provide written informed consent to participate in the clinical trial Exclusion Criteria: Individuals with dyslipidemia and eligible to receive or already receiving statin therapy Pregnant or lactating mothers Individuals with another active or controlled inflammatory condition Individuals with deranged liver function tests 3 fold and above
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Damalie Nakanjako, PhD
    Phone
    +256772411273
    Email
    dnakanjako@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rose Nabatanzo, MSC
    Phone
    +256772603646
    Email
    rosemagala@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Damalie Nakanjako, PhD
    Organizational Affiliation
    Makerere University College of Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be shared with the Infectious Diseases Institute, according to the IDI data sharing policy
    Citations:
    PubMed Identifier
    25514794
    Citation
    Funderburg NT, Jiang Y, Debanne SM, Labbato D, Juchnowski S, Ferrari B, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin reduces vascular inflammation and T-cell and monocyte activation in HIV-infected subjects on antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478.
    Results Reference
    result
    PubMed Identifier
    25441397
    Citation
    Nakanjako D, Ssinabulya I, Nabatanzi R, Bayigga L, Kiragga A, Joloba M, Kaleebu P, Kambugu AD, Kamya MR, Sekaly R, Elliott A, Mayanja-Kizza H. Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial. Trop Med Int Health. 2015 Mar;20(3):380-90. doi: 10.1111/tmi.12442. Epub 2015 Jan 6.
    Results Reference
    result

    Learn more about this trial

    Statin Adjunct Therapy Among ART-treated Adults in Sub-Saharan Africa: Atorvastatin and Rosuvastatin Equivalence Trial

    We'll reach out to this number within 24 hrs