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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03037372

Acronym

STAR

Enrollment

320

Registered

2017-01-31

Start date

2017-06-01

Completion date

2022-12-31

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

adults, antiretroviral therapy

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

Interventions

DRUGART, Atorvastatin

ART, Atorvastatin

DRUGART, Rosuvastatin

ART, Rosuvastatin

DRUGART, No statin

ART, No statin

DRUGHealthy-HIV-negative

Age-matched, Healthy HIV-negative

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactDamalie Nakanjako, PhD

dnakanjako@gmail.com+256772411273

Backup ContactRose Nabatanzo, MSC

rosemagala@gmail.com+256772603646

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026