Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks

NCT01218802 | Completed Phase 2 Results DMC

• 1 other identifier: 1R01NR012642-01
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in decreasing cardiovascular risk and bone loss in the HIV+ population.

Conditions

HIV Infections; Heart Disease

Keywords

HIV; Heart Disease; Bone Density

Outcome Measures

Primary Outcomes (2)

• Bone Mineral Density (BMD)

  Measured by change in bone DEXA from baseline to week 96

  96 weeks

• Carotid IMT

  changes in carotid IMT is a good measure for cardiovascular disease progression

  96 weeks

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

Participants will take Rosuvastatin 10 mg. daily for 96 weeks

Drug: Rosuvastatin 10 mg. daily for 96 weeks

Sugar Pill placebo

PLACEBO COMPARATOR

Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.

Drug: Placebo

Interventions

Rosuvastatin 10 mg. daily for 96 weeks DRUG

Participants will take Rosuvastatin 10 mg. daily for 96 weeks.

Also known as: Crestor

Rosuvastatin

Placebo DRUG

participants will take a sugar pill daily for 96 weeks

Sugar Pill placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of HIV Disease
• Age \> 18 years old
• Receiving a stable ARV regimen for at least the last 12 weeks prior to study entry and cumulative duration of ARV for 12 months
• Fasting LDL cholesterol \< 130 mg/dl
• Fasting triglycerides \< 300 mg/dL
• hsCRP \> 2 mg/L or CD38+DR+/CD8+ \> 19%
• If on Vit D replacement therapy, stable regimen for \> 3 months prior to study entry

You may not qualify if:

• Women who are pregnant or breast feeding
• Any active or chronic inflammatory condition
• Cardiovascular disease
• Current or recent (within 24 weeks of study entry) therapy with omega-3 fatty acids, fibrates, ezetimibe or statins
• Uncontrolled hypothyroidism or hyperthyroidism
• Uncontrolled diabetes
• Use of systemic cancer chemotherapy of immunomodulating agents
• Use of Anabolic agents, growth hormone, growth hormone releasing factor, or any other anabolic agents, except for stable replacement testosterone.
• Use of biphosphonates or other bone therapies
• Any of the following lab findings obtained within 14 days prior to the screening evaluation including the following:
• AST and/or ALT \> 2.5 x ULN
• Hemoglobin \< 9.0 g/dL
• CK \> 3 X ULN
• Calculated creatinine clearance \< 50 mL/min

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• National Institutes of Health (NIH): collaborator
• AstraZeneca: collaborator

Study Sites (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (11)

• El Kamari V, Hileman CO, Gholam PM, Kulkarni M, Funderburg N, McComsey GA. Statin Therapy Does Not Reduce Liver Fat Scores in Patients Receiving Antiretroviral Therapy for HIV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):536-542.e1. doi: 10.1016/j.cgh.2018.05.058. Epub 2018 Jun 14.

  PMID: 29908359 DERIVED

• Dirajlal-Fargo S, Webel AR, Longenecker CT, Kinley B, Labbato D, Sattar A, McComsey GA. The effect of physical activity on cardiometabolic health and inflammation in treated HIV infection. Antivir Ther. 2016;21(3):237-45. doi: 10.3851/IMP2998. Epub 2015 Oct 12.

  PMID: 26455521 DERIVED

• Hale AT, Longenecker CT, Jiang Y, Debanne SM, Labatto DE, Storer N, Hamik A, McComsey GA. HIV vasculopathy: role of mononuclear cell-associated Kruppel-like factors 2 and 4. AIDS. 2015 Aug 24;29(13):1643-50. doi: 10.1097/QAD.0000000000000756.

  PMID: 26372274 DERIVED

• Hileman CO, Dirajlal-Fargo S, Lam SK, Kumar J, Lacher C, Combs GF Jr, McComsey GA. Plasma Selenium Concentrations Are Sufficient and Associated with Protease Inhibitor Use in Treated HIV-Infected Adults. J Nutr. 2015 Oct;145(10):2293-9. doi: 10.3945/jn.115.214577. Epub 2015 Aug 12.

  PMID: 26269240 DERIVED

• Erlandson KM, Jiang Y, Debanne SM, McComsey GA. Rosuvastatin Worsens Insulin Resistance in HIV-Infected Adults on Antiretroviral Therapy. Clin Infect Dis. 2015 Nov 15;61(10):1566-72. doi: 10.1093/cid/civ554. Epub 2015 Jul 8.

  PMID: 26157049 DERIVED

• Lipshultz HM, Hileman CO, Ahuja S, Funderburg NT, McComsey GA. Anaemia is associated with monocyte activation in HIV-infected adults on antiretroviral therapy. Antivir Ther. 2015;20(5):521-7. doi: 10.3851/IMP2940. Epub 2015 Feb 10.

  PMID: 25668820 DERIVED

• 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 DERIVED

• Longenecker CT, Hileman CO, Funderburg NT, McComsey GA. Rosuvastatin preserves renal function and lowers cystatin C in HIV-infected subjects on antiretroviral therapy: the SATURN-HIV trial. Clin Infect Dis. 2014 Oct 15;59(8):1148-56. doi: 10.1093/cid/ciu523. Epub 2014 Jul 11.

  PMID: 25015912 DERIVED

• Longenecker CT, Jiang Y, Orringer CE, Gilkeson RC, Debanne S, Funderburg NT, Lederman MM, Storer N, Labbato DE, McComsey GA. Soluble CD14 is independently associated with coronary calcification and extent of subclinical vascular disease in treated HIV infection. AIDS. 2014 Apr 24;28(7):969-77. doi: 10.1097/QAD.0000000000000158.

  PMID: 24691204 DERIVED

• Funderburg NT, Jiang Y, Debanne SM, Storer N, Labbato D, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin treatment reduces markers of monocyte activation in HIV-infected subjects on antiretroviral therapy. Clin Infect Dis. 2014 Feb;58(4):588-95. doi: 10.1093/cid/cit748. Epub 2013 Nov 18.

  PMID: 24253250 DERIVED

• Longenecker CT, Funderburg NT, Jiang Y, Debanne S, Storer N, Labbato DE, Lederman MM, McComsey GA. Markers of inflammation and CD8 T-cell activation, but not monocyte activation, are associated with subclinical carotid artery disease in HIV-infected individuals. HIV Med. 2013 Jul;14(6):385-90. doi: 10.1111/hiv.12013. Epub 2013 Jan 18.

  PMID: 23332012 DERIVED

MeSH Terms

Conditions

HIV Infections; Heart Diseases

Interventions

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; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Grace McComsey, MD
• Organization: Case Western Reserve University

gam9@case.edu

2168442739

Study Officials

• Grace McComsey, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Peds ID, Rheumatology and Global Health

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: February 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 8, 2016
• Results First Posted: March 8, 2016

Record last verified: 2016-03

Locations

US (1)