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

HIV Infection Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03037372
• Other study ID #: DN2017
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 10, 2017
• Last updated: January 26, 2017
• Start date: June 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2017
• Source: Makerere University
• Contact: Damalie Nakanjako, PhD
• Phone: +256772411273
• Email: dnakanjako[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This is a randomized, open-label trial

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• ART, Atorvastatin
ART, Atorvastatin
• ART, Rosuvastatin
ART, Rosuvastatin
• ART, No statin
ART, No statin
• Healthy-HIV-negative
Age-matched, Healthy HIV-negative

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Makerere University	Case Western Reserve University, University of Oxford

References & Publications (2)

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 Ac — View 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 responde — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05)	measured by percentage of HLADR+CD38+T-cells	12 months
Secondary	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	36 months
Secondary	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	36 months
Secondary	Biological pathways affected by atorvastatin and rosuvastatin	number of genes down-regulated by either atorvastatin or rosuvastatin	36 months