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

Makerere University

Status and phase: Unknown; Phase 3

Conditions: HIV Infection

Treatments: Drug: Healthy-HIV-negative; Drug: ART, No statin; Drug: ART, Rosuvastatin; Drug: ART, Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03037372

DN2017

Details and patient eligibility

About

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

Full description

This is a randomized, open-label trial

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 4 patient groups

ART-Atorvastatin adjunct therapy

Experimental group

Description:

ART, atorvastatin

Treatment:

Drug: ART, Atorvastatin

ART-Rosuvastatin adjunct therapy

Experimental group

Description:

ART, rosuvastatin

Treatment:

Drug: ART, Rosuvastatin

ART-without statin adjunct therapy

Experimental group

Description:

ART, no statin

Treatment:

Drug: ART, No statin

Healthy-HIV-negative

Experimental group

Description:

Age-matched HIV-negative, healthy volunteers from the same community

Treatment:

Drug: Healthy-HIV-negative