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

January 26, 2017 updated by: Makerere University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, open-label trial

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ART-Atorvastatin adjunct therapy
ART, atorvastatin
Drug: ART, Atorvastatin
ART, Atorvastatin
Other Names:
  • Atovastatin adjunct therapy
Experimental: ART-Rosuvastatin adjunct therapy
ART, rosuvastatin
Drug: ART, Rosuvastatin
ART, Rosuvastatin
Other Names:
  • Rosuvastatin adjunct therapy
Experimental: ART-without statin adjunct therapy
ART, no statin
Drug: ART, No statin
ART, No statin
Other Names:
  • No statin adjunct therapy
Experimental: Healthy-HIV-negative
Age-matched HIV-negative, healthy volunteers from the same community
Drug: Healthy-HIV-negative
Age-matched, Healthy HIV-negative
Other Names:
  • HIV-negative controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05)
Time Frame: 12 months
measured by percentage of HLADR+CD38+T-cells
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 36 months
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
36 months
Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05)
Time Frame: 36 months
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
36 months
Biological pathways affected by atorvastatin and rosuvastatin
Time Frame: 36 months
number of genes down-regulated by either atorvastatin or rosuvastatin
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Collaborators

University of Oxford
Case Western Reserve University

Investigators

  • Principal Investigator: Damalie Nakanjako, PhD, Makerere University College of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DN2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with the Infectious Diseases Institute, according to the IDI data sharing policy

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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