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
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring adults, antiretroviral therapy
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
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
NCT ID
NCT03037372
First Posted
January 10, 2017
Last Updated
January 26, 2017
Sponsor
Makerere University
Collaborators
University of Oxford, Case Western Reserve University
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
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