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

Phase 3

• Conditions: HIV Infection
• Interventions: Drug: ART, Atorvastatin; Drug: ART, No statin; Drug: ART, Rosuvastatin; Drug: Healthy-HIV-negative

• Registration Number: NCT03037372
• Lead Sponsor: 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

Detailed Description

This is a randomized, open-label trial

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-26
• Last Update Submitted: 2017-01-26
• Study First Posted: 2017-01-31
• Last Update Posted: 2017-01-31
• Study Start: 2017-06-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ART-Atorvastatin adjunct therapy	ART, Atorvastatin	ART, atorvastatin
ART-without statin adjunct therapy	ART, No statin	ART, no statin
ART-Rosuvastatin adjunct therapy	ART, Rosuvastatin	ART, rosuvastatin
Healthy-HIV-negative	Healthy-HIV-negative	Age-matched HIV-negative, healthy volunteers from the same community

Primary Outcome Measures

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

Secondary Outcome Measures

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