HIV SeropositivityEarly Phase 1SPARCNCT01881971
Statins for Pulmonary and Cardiac Complications of Chronic HIV - Coordinating Center
A Early Phase 1 study testing Rouvastatin calcium in people with HIV Seropositivity, run by Alison Morris at 3 sites in United States.
Trial summary
Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- Rouvastatin calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2013to Jan 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.).
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- 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.
- Use of azole antifungals, erythromycin, or amiodarone.
- More than weekly use of magnesium hydroxide.
- The intention to quit smoking during the study period.
- Alcoholism defined as >35 drinks per week or that will impair ability to complete study investigations in the opinion of the investigator.
- Active (within the past 6 months) intravenous drug use or that will impair ability to complete study investigations in the opinion of the investigator.
- Use of other investigational agents within 90 days of study entry or planning on entering another therapy trial during study period.
- No use of inhaled corticosteroids (beta-agonists are allowed).
- Viral load above 50 in past 3 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, Los Angelos
Los Angeles, California, 90095
University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine
Pittsburgh, Pennsylvania, 15213
University of California, SF
San Francisco, California, 94118
About this study
Official title: Multicenter, Prospective Adaptive Response Placebo-controlled Double-blind Study Comparing Effects of Rosuvastatin Versus Placebo
Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.
Read the detailed description
Growing evidence indicates that chronic obstructive pulmonary disease (COPD) is an important cause of respiratory impairment in HIV+ persons and will likely increase as the HIV+ population continues to age. In the HIV-uninfected population, COPD frequently co-exists with cardiac disease including atherosclerosis and pulmonary hypertension (PH). The investigators work has demonstrated that a syndrome of "cardiopulmonary dysfunction" exists even in non-smoking or antiretroviral-treated HIV+ individuals. The investigators have found that HIV+ individuals have a high prevalence of respiratory symptoms, airflow obstruction, and diffusing capacity (DLco) abnormalities that occur concurrently with cardiac co-morbidities, including radiographic measures of atherosclerosis and elevated echocardiographic pulmonary artery pressures. This syndrome is marked by inflammation with elevated levels of cytokines and hsCRP, peripheral T-cell activation, and increased sputum neutrophils as well as elevation of NT-proBNP, a marker of heart strain. Importantly, the investigators have shown that DLco impairment and elevated NT-proBNP are significant independent predictors of mortality in HIV, indicating that cardiopulmonary dysfunction is likely highly clinically relevant and identifies a vulnerable population in whom the investigators lack effective interventions.
Statins have anti-inflammatory effects in the lung and vasculature that might benefit cardiopulmonary dysfunction in HIV. These agents have a long history of clinical use in cardiovascular disease and are currently being investigated as disease-modifying drugs for HIV, COPD, and PH. In preliminary analyses, the investigators have found that HIV+ individuals who received statin therapy within the past year were significantly less likely to have impaired DLco and had lower pulmonary artery pressures, lower NT-proBNP, lower peripheral cytokines, and fewer sputum neutrophils despite being older and having a greater smoking history than those not using statins.
- Conditions
- HIV Seropositivity
- Being tested
- Placebo, Rouvastatin calcium
- Keywords
- HIV, lung, lipids, no lipid lowering medication, normal liver and kidney function, on stable ART regimen, not pregnant
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
suger pill manufactured to mimic crestor pills
Rouvastatin calciumDrug
Also called Crestor
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | manufactured sugar pill to mimic rouvastatin once a day for 24 weeks Receives: Drug: Placebo |
| Rouvastatin calcium | Experimental | Rouvastatin calcium once a day by mouth for 24 weeks. Receives: Drug: Rouvastatin calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in inflammatory markers - hsCRP
To assess change in hsCRP after 24 weeks of therapy with rosuvastatin
Measured: 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
noninvsive Vascular cIMT, FMD and Glycocalyx will be measured at the beginning and at the end of the study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alison Morris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alison Morris, University of Pittsburgh
- Investigators
- Alison M Morris, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881971
- Sponsor's protocol ID
- PRO12100503
- Other IDs
- RFA-HL-12-034
- Acronym
- SPARC
- Status last verified
- Oct 2020
- First submitted
- 2 Apr 2013
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27941393
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Adaptive Response Placebo-controlled Double-blind Study Comparing Effects of Rosuvastatin Versus Placebo
- ClinicalTrials.gov ID
- NCT01881971
- Acronym / sponsor ID
- SPARC / PRO12100503
- Conditions
- HIV Seropositivity
- Keywords
- HIV, lung, lipids, no lipid lowering medication, normal liver and kidney function, on stable ART regimen, not pregnant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Alison MorrisUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.
Detailed description
Growing evidence indicates that chronic obstructive pulmonary disease (COPD) is an important cause of respiratory impairment in HIV+ persons and will likely increase as the HIV+ population continues to age. In the HIV-uninfected population, COPD frequently co-exists with cardiac disease including atherosclerosis and pulmonary hypertension (PH). The investigators work has demonstrated that a syndrome of "cardiopulmonary dysfunction" exists even in non-smoking or antiretroviral-treated HIV+ individuals. The investigators have found that HIV+ individuals have a high prevalence of respiratory symptoms, airflow obstruction, and diffusing capacity (DLco) abnormalities that occur concurrently with cardiac co-morbidities, including radiographic measures of atherosclerosis and elevated echocardiographic pulmonary artery pressures. This syndrome is marked by inflammation with elevated levels of cytokines and hsCRP, peripheral T-cell activation, and increased sputum neutrophils as well as elevation of NT-proBNP, a marker of heart strain. Importantly, the investigators have shown that DLco impairment and elevated NT-proBNP are significant independent predictors of mortality in HIV, indicating that cardiopulmonary dysfunction is likely highly clinically relevant and identifies a vulnerable population in whom the investigators lack effective interventions.
Statins have anti-inflammatory effects in the lung and vasculature that might benefit cardiopulmonary dysfunction in HIV. These agents have a long history of clinical use in cardiovascular disease and are currently being investigated as disease-modifying drugs for HIV, COPD, and PH. In preliminary analyses, the investigators have found that HIV+ individuals who received statin therapy within the past year were significantly less likely to have impaired DLco and had lower pulmonary artery pressures, lower NT-proBNP, lower peripheral cytokines, and fewer sputum neutrophils despite being older and having a greater smoking history than those not using statins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebomanufactured sugar pill to mimic rouvastatin once a day for 24 weeks |
| Rouvastatin calcium | Experimental | Drug: Rouvastatin calciumRouvastatin calcium once a day by mouth for 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebosuger pill manufactured to mimic crestor pills | Drug | Placebo |
| Rouvastatin calciumAlso: Crestor | Drug | Rouvastatin calcium |
Primary outcome
change in inflammatory markers - hsCRP
Time frame: 24 weeks
To assess change in hsCRP after 24 weeks of therapy with rosuvastatin
1 secondary outcome
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
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 27941393Morris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison M Morris, MD, MS principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rouvastatin calcium in people with HIV Seropositivity, run by Alison Morris at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in inflammatory markers - hsCRP (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.