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

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ClinicalTrials.gov Identifier: NCT03037372
Recruitment Status : Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Collaborators:
University of Oxford
Case Western Reserve University
Information provided by (Responsible Party):
Makerere University

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

Condition or disease Intervention/treatment Phase
HIV Infection Drug: ART, Atorvastatin Drug: ART, Rosuvastatin Drug: ART, No statin Drug: Healthy-HIV-negative Phase 3

Detailed Description:
This is a randomized, open-label trial

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa: Equivalence of Atorvastatin and Rosuvastatin
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ART-Atorvastatin adjunct therapy
ART, atorvastatin
Drug: ART, Atorvastatin
ART, Atorvastatin
Other Name: Atovastatin adjunct therapy

Experimental: ART-Rosuvastatin adjunct therapy
ART, rosuvastatin
Drug: ART, Rosuvastatin
ART, Rosuvastatin
Other Name: Rosuvastatin adjunct therapy

Experimental: ART-without statin adjunct therapy
ART, no statin
Drug: ART, No statin
ART, No statin
Other Name: 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 Name: HIV-negative controls




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Biological pathways affected by atorvastatin and rosuvastatin [ Time Frame: 36 months ]
    number of genes down-regulated by either atorvastatin or rosuvastatin



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037372


Contacts
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Contact: Damalie Nakanjako, PhD +256772411273 dnakanjako@gmail.com
Contact: Rose Nabatanzo, MSC +256772603646 rosemagala@gmail.com

Sponsors and Collaborators
Makerere University
University of Oxford
Case Western Reserve University
Investigators
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Principal Investigator: Damalie Nakanjako, PhD Makerere University College of Health Sciences

Publications of Results:
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT03037372     History of Changes
Other Study ID Numbers: DN2017
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with the Infectious Diseases Institute, according to the IDI data sharing policy

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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

Keywords provided by Makerere University:
adults
antiretroviral therapy

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atorvastatin
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors