NCT01881971

Brief Summary

Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2013

Typical duration for early_phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.5 years

First QC Date

April 2, 2013

Last Update Submit

October 6, 2020

Conditions

HIV Seropositivity

Keywords

HIVlunglipidsno lipid lowering medicationnormal liver and kidney functionon stable ART regimennot pregnant

Outcome Measures

Primary Outcomes (1)

  • change in inflammatory markers - hsCRP

    To assess change in hsCRP after 24 weeks of therapy with rosuvastatin

    24 weeks

Secondary Outcomes (1)

  • effect of rosuvastatin on pulmonary and cardiac status by use of cIMT/FMD/ Vascular studies are a measure of preclinical atherosclerosis and predicts future cardiovascular events and mortality

    2 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

manufactured sugar pill to mimic rouvastatin once a day for 24 weeks

Drug: Placebo

Rouvastatin calcium

EXPERIMENTAL

Rouvastatin calcium once a day by mouth for 24 weeks.

Drug: Rouvastatin calcium

Interventions

PlaceboDRUG

suger pill manufactured to mimic crestor pills

Placebo
Rouvastatin calciumDRUG
Also known as: Crestor
Rouvastatin calcium

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infection, documented in medical record at any time prior to study entry.
  • Men and women age18 years to 80 years.
  • Presence of COPD (FEV1/FVC\<0.70 or DLco≤80% predicted)
  • No lipid-lowering medication (prescription or non-prescription) within 60 days prior to study entry. This includes all statin drugs, omega-3-fatty acids/fish oil (if dose \> 1 g/day), red yeast rice (any dose), and niacin products (e.g., niacin, nicotinic acid, vitamin B3; if dose of \>100 mg/day)
  • Normal liver and kidney function test at screening visit:
  • Liver function: ALT 7 to 55 U/L; AST 8 to 48 U/L; ALP 45 to 115 U/L; Bilirubin 0.1 to 1.0 mg/dL; GGT 9 to 48 U/L; LDH 122 to 222 umol/L; PT 8.3 to 10.8 seconds
  • Kidney function: BUN 8-20 mg/dl. Creatinine 0.8-1.2 mg/dl for males and 0.6-0.9 mg/dl for females. GFR normal results range from 90 - 120 mL/min/1.73 m2.) Participants will be on a stable ART regimen (i.e. no change in agents) with either suppressed HIV viral level or \<50 viral level for at least 3 months.
  • If smoker, not planning on quitting smoking during the study period. If non-smoker, not planning on starting smoking during the study period.
  • Able to provide informed consent.
  • Able to participate in study procedures based on the investigator's assessment.
  • For women of reproductive potential, negative urine pregnancy test and willingness to use birth control during study period (see Contraception requirements).
  • Ability and willingness to complete all tests.
  • Participant in MACS, Women's Interagency Health Study, or Attendee of UPMC HIV / AIDS Program.

You may not qualify if:

  • Pregnancy or breast-feeding.
  • Known allergy/sensitivity or any hypersensitivity to HMG CoA reductase inhibitors, prior history of myopathy, rhabdomyolysis, or intolerance of statin therapy.
  • Currently receiving a statin or should be taking a statin based on clinical criteria.
  • Concurrent use of Coumadin.
  • History of liver disease.
  • Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
  • Diagnosis of asthma with normal diffusing capacity.
  • History of diabetes mellitus requiring medication of hemoglobin A1C\>6.5% on screening laboratories.
  • Increasing respiratory symptoms or febrile (temperature \>100.40F \[380C\]) within 4 weeks of study entry.
  • Hospitalization within 4 weeks prior to study entry.
  • Use of antibiotics within 4 weeks of study entry.
  • Uncontrolled hypertension at screening visit (systolic \> 160 mm Hg or diastolic \> 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.
  • Active cancer requiring systemic chemotherapy or radiation.
  • Active infection of lungs, brain, or abdomen.
  • Use of anti-inflammatory agents (such as aspirin), immunomodulators (e.g., interleukins, interferons, cyclosporine) or immunosuppressive medications within 60 days prior to study entry. Routine vaccinations are allowed if administered at least 7 days prior to study entry.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Los Angelos

Los Angeles, California, 90095, United States

Location

University of California, SF

San Francisco, California, 94118, United States

Location

University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Morris A, Fitzpatrick M, Bertolet M, Qin S, Kingsley L, Leo N, Kessinger C, Michael H, Mcmahon D, Weinman R, Stone S, Leader JK, Kleerup E, Huang L, Wisniewski SR. Use of rosuvastatin in HIV-associated chronic obstructive pulmonary disease. AIDS. 2017 Feb 20;31(4):539-544. doi: 10.1097/QAD.0000000000001365.

    PMID: 27941393BACKGROUND

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alison M Morris, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2013

First Posted

June 20, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

US(3)