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

NCT ID: NCT03037372

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-12-31

Brief Summary

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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

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This is a randomized, open-label trial

Conditions

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HIV Infection

Keywords

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adults antiretroviral therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ART-Atorvastatin adjunct therapy

ART, atorvastatin

Group Type EXPERIMENTAL

ART, Atorvastatin

Intervention Type DRUG

ART, Atorvastatin

ART-Rosuvastatin adjunct therapy

ART, rosuvastatin

Group Type EXPERIMENTAL

ART, Rosuvastatin

Intervention Type DRUG

ART, Rosuvastatin

ART-without statin adjunct therapy

ART, no statin

Group Type EXPERIMENTAL

ART, No statin

Intervention Type DRUG

ART, No statin

Healthy-HIV-negative

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

Group Type EXPERIMENTAL

Healthy-HIV-negative

Intervention Type DRUG

Age-matched, Healthy HIV-negative

Interventions

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ART, Atorvastatin

ART, Atorvastatin

Intervention Type DRUG

ART, Rosuvastatin

ART, Rosuvastatin

Intervention Type DRUG

ART, No statin

ART, No statin

Intervention Type DRUG

Healthy-HIV-negative

Age-matched, Healthy HIV-negative

Intervention Type DRUG

Other Intervention Names

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Atovastatin adjunct therapy Rosuvastatin adjunct therapy No statin adjunct therapy HIV-negative controls

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damalie Nakanjako, PhD

Role: PRINCIPAL_INVESTIGATOR

Makerere University College of Health Sciences

Central Contacts

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Damalie Nakanjako, PhD

Role: CONTACT

Phone: +256772411273

Email: [email protected]

Rose Nabatanzo, MSC

Role: CONTACT

Phone: +256772603646

Email: [email protected]

References

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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 Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478.

Reference Type RESULT
PMID: 25514794 (View on PubMed)

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 responders in Uganda: a randomised crossover placebo-controlled trial. Trop Med Int Health. 2015 Mar;20(3):380-90. doi: 10.1111/tmi.12442. Epub 2015 Jan 6.

Reference Type RESULT
PMID: 25441397 (View on PubMed)

Other Identifiers

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DN2017

Identifier Type: -

Identifier Source: org_study_id