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

NCT03037372 | Unknown Phase 3 DMC

• 1 other identifier: DN2017
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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

Conditions

HIV Infection

Keywords

adults; antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05)

  36 months

• Biological pathways affected by atorvastatin and rosuvastatin

  36 months

Study Arms (4)

ART-Atorvastatin adjunct therapy

EXPERIMENTAL

ART, atorvastatin

Drug: ART, Atorvastatin

ART-Rosuvastatin adjunct therapy

EXPERIMENTAL

ART, rosuvastatin

Drug: ART, Rosuvastatin

ART-without statin adjunct therapy

EXPERIMENTAL

ART, no statin

Drug: ART, No statin

Healthy-HIV-negative

EXPERIMENTAL

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

Drug: Healthy-HIV-negative

Interventions

ART, Atorvastatin DRUG

ART, Atorvastatin

Also known as: Atovastatin adjunct therapy

ART-Atorvastatin adjunct therapy

ART, Rosuvastatin DRUG

ART, Rosuvastatin

Also known as: Rosuvastatin adjunct therapy

ART-Rosuvastatin adjunct therapy

ART, No statin DRUG

ART, No statin

Also known as: No statin adjunct therapy

ART-without statin adjunct therapy

Healthy-HIV-negative DRUG

Age-matched, Healthy HIV-negative

Also known as: HIV-negative controls

Healthy-HIV-negative

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead
• University of Oxford: collaborator
• Case Western Reserve University: collaborator

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

  PMID: 25514794 RESULT

• 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.

  PMID: 25441397 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Damalie Nakanjako, PhD

  Makerere University College of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damalie Nakanjako, PhD

CONTACT

+256772411273; dnakanjako@gmail.com

Rose Nabatanzo, MSC

CONTACT

+256772603646; rosemagala@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 31, 2017
• Study Start: June 1, 2017
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share