HIV InfectionNCT00982189

Cardiovascular Prevention for Persons With HIV

A study testing Pravastatin and Lisinopril in people with HIV Infection and Cardiovascular Disease Risk, run by Hennepin Healthcare Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: HIV Infection, Cardiovascular Disease Risk
What is being tested?: Pravastatin and Lisinopril
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Sep 2009to May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV Infection with viral load 'undetectable' while taking antiretroviral therapy
Age ≥40
Framingham risk score (FRS) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy

Who cannot join

Known cardiovascular disease or Framingham risk score (FRS) ≥20%
Blood pressure ≥140/90
LDL cholesterol ≥160 (with FRS <10%), or ≥130 (with FRS 10-20%)
Currently taking, or has a medication contraindication to take, a 'statin', an ACE inhibitor, or an angiotensin receptor blocker medication
Cirrhosis or plasma ALT/AST levels >2x upper limit of normal
Chronic kidney disease and a creatinine >2.0mg/dL
Triglycerides >500mg/dL

Trial locations and contacts

1 site in 1 country.

United States1 site

Hennepin County Medical Center
Minneapolis, Minnesota, 55415

Other trials in United States

About this study

Official title: Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study

This study is funded by the American Heart Association. The goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with HIV infection. Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such as the case with HIV infection).

Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at 3 study visits over 4 months.

Conditions: HIV Infection, Cardiovascular Disease Risk
Being tested: Pravastatin, Lisinopril
Keywords: treatment experienced
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PravastatinDrug
Participants randomized to take pravastatin (active) or matching placebo pill once daily
LisinoprilDrug
Participants randomized to take lisinopril (active) or matching placebo pill once daily

Study groups in NCT00982189
Study group	Role	What they receive
Lisinopril	Experimental	Lisinopril 10mg once daily Receives: Drug: Lisinopril
Lisinopril Placebo	Placebo comparator	Placebo pill (matched to lisinopril) once daily Receives: Drug: Lisinopril
Pravastatin	Experimental	Pravastatin 20mg once daily Receives: Drug: Pravastatin
Pravastatin placebo	Placebo comparator	Placebo pill (matched to pravastatin) once daily Receives: Drug: Pravastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Stated (by Self-report) That They Had Side Effects
Participants were asked at each visit if they had any side effects to study medication. They provided a yes or no answer, and if yes they specified what the side effect was.
Measured: 4 months
Number of Participants Who Took >90% of Their Doses (by Pill Count)
The number of pills missing from study medication bottles was counted by study nurses at the completion of the study. The proportion of pills taken divided by the number of days the participant was enrolled in the study was calculated, and multiplied by 100, to generate the '% of doses taken'
Measured: 4 months
Change From Baseline to Month 4 in the Framingham Risk Score (FRS)
The Framingham Risk Score is calculated by a published algorithm that predicts a patients risk of having a coronary heart disease event in the next 10 years. The measures that are considering in predicting this risk are: age, blood pressure, cholesterol (both total cholesterol and high-density lipoprotein cholesterol), smoking status, and use of medication to treat hypertension. This risk score can be estimated using an online calculator (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
Measured: Change from baseline to 4 months

Secondary outcomes (6)

Changes in Blood Pressure
Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit)
Measured: change from baseline to 4 months
Changes in Blood Lipids
Blood lipids include routine cholesterol measurements that are monitored in clinical practice. They are measured in blood after a blood draw is performed. The specific measurements include: a) total cholesterol, b) low-density lipoprotein cholesterol, c) high-density lipoprotein cholesterol, and d) triglycerides
Measured: change from baseline to 4 months
Changes in Small Artery Elasticity
Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.
Measured: change from baseline to 4 months
Changes hsCRP (C-reactive Protein)
This biomarker represents systemic inflammation within in the body.
Measured: change from baseline to 4 months
Changes IL-6 (Interleukin-6)
This biomarker represents systemic inflammation within in the body.
Measured: change from baseline to 4 months
Changes TNFa (Tumor Necrosis Factor Alpha)
This biomarker represents systemic inflammation within in the body.
Measured: change from baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009May 2011

First posted23 Sep 2009 (estimated)
Study startSep 2009
Primary completionDec 2010
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies 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: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00982189
Sponsor's protocol ID: PCC-003
Status last verified: Oct 2017
First submitted: 22 Sep 2009
Last updated: 22 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Baker JV, Huppler Hullsiek K, Prosser R, Duprez D, Grimm R, Tracy RP, Rhame F, Henry K, Neaton JD. Angiotensin converting enzyme inhibitor and HMG-CoA reductase inhibitor as adjunct treatment for persons with HIV infection: a feasibility randomized trial. PLoS One. 2012;7(10):e46894. doi: 10.1371/journal.pone.0046894. Epub 2012 Oct 17.
PubMed 23082133

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study
ClinicalTrials.gov ID: NCT00982189
Acronym / sponsor ID: PCC-003
Conditions: HIV Infection, Cardiovascular Disease Risk
Keywords: treatment experienced
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Hennepin Healthcare Research InstituteUniversity, hospital or other
Collaborators: American Heart Association
Study start: Sep 2009
Primary completion: Dec 2010 (actual)
Study completion: May 2011 (actual)
First posted: 23 Sep 2009 (estimated)
Results: Posted 18 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Lisinopril	Experimental	Drug: LisinoprilLisinopril 10mg once daily
Lisinopril Placebo	Placebo comparator	Drug: LisinoprilPlacebo pill (matched to lisinopril) once daily
Pravastatin	Experimental	Drug: PravastatinPravastatin 20mg once daily
Pravastatin placebo	Placebo comparator	Drug: PravastatinPlacebo pill (matched to pravastatin) once daily

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

HIV Infection with viral load 'undetectable' while taking antiretroviral therapy
Age ≥40
Framingham risk score (FRS) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy

Key exclusion criteria (7 listed)

Known cardiovascular disease or Framingham risk score (FRS) ≥20%
Blood pressure ≥140/90
LDL cholesterol ≥160 (with FRS <10%), or ≥130 (with FRS 10-20%)
Currently taking, or has a medication contraindication to take, a 'statin', an ACE inhibitor, or an angiotensin receptor blocker medication
Cirrhosis or plasma ALT/AST levels >2x upper limit of normal

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
PravastatinParticipants randomized to take pravastatin (active) or matching placebo pill once daily	Drug	Pravastatin, Pravastatin placebo
LisinoprilParticipants randomized to take lisinopril (active) or matching placebo pill once daily	Drug	Lisinopril, Lisinopril Placebo

Primary outcome

Number of Participants Who Stated (by Self-report) That They Had Side Effects
Time frame: 4 months
Participants were asked at each visit if they had any side effects to study medication. They provided a yes or no answer, and if yes they specified what the side effect was.
Number of Participants Who Took >90% of Their Doses (by Pill Count)
Time frame: 4 months
The number of pills missing from study medication bottles was counted by study nurses at the completion of the study. The proportion of pills taken divided by the number of days the participant was enrolled in the study was calculated, and multiplied by 100, to generate the '% of doses taken'
Change From Baseline to Month 4 in the Framingham Risk Score (FRS)
Time frame: Change from baseline to 4 months
The Framingham Risk Score is calculated by a published algorithm that predicts a patients risk of having a coronary heart disease event in the next 10 years. The measures that are considering in predicting this risk are: age, blood pressure, cholesterol (both total cholesterol and high-density lipoprotein cholesterol), smoking status, and use of medication to treat hypertension. This risk score can be estimated using an online calculator (http://hp2010.nhlbihin.net/atpiii/calculator.asp)

6 secondary outcomes

Changes in Blood Pressure
Time frame: change from baseline to 4 months
Changes in Blood Lipids
Time frame: change from baseline to 4 months
Changes in Small Artery Elasticity
Time frame: change from baseline to 4 months
Changes hsCRP (C-reactive Protein)
Time frame: change from baseline to 4 months
Changes IL-6 (Interleukin-6)
Time frame: change from baseline to 4 months
Changes TNFa (Tumor Necrosis Factor Alpha)
Time frame: change from baseline to 4 months

Results and safety

Results posted to the registry on 18 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lisinopril/P-placebo	10	10
L-placebo/Pravastatin	9	9
Lisinopril/Pravastatin	9	9
L-placebo/P-placebo	9	9

Primary outcome: Number of Participants Who Stated (by Self-report) That They Had Side Effects

Time frame: 4 months. Number. Unit: participants

Measure	Lisinopril/P-placebo n = 10	L-placebo/Pravastatin n = 9	Lisinopril/Pravastatin n = 9	L-placebo/P-placebo n = 9
Value	1	0	2	1

Population analysed: Number of participants who stated (by self-report) that they had side effects

Primary outcome: Number of Participants Who Took >90% of Their Doses (by Pill Count)

Time frame: 4 months. Number. Unit: participants

Measure	Lisinopril/P-placebo n = 4	L-placebo/Pravastatin n = 7	Lisinopril/Pravastatin n = 8	L-placebo/P-placebo n = 6
Value	2	7	5	6

Population analysed: Number of participants who took \>90% of their doses (by pill count)were studied. All participants who returned unused medications at end of the study were included for these analyses

Primary outcome: Change From Baseline to Month 4 in the Framingham Risk Score (FRS)

Time frame: Change from baseline to 4 months. Median (Inter-Quartile Range). Unit: Percent probability of CHD event in 10yr

Measure	Lisinopril/P-placebo n = 10	L-placebo/Pravastatin n = 9	Lisinopril/Pravastatin n = 9	L-placebo/P-placebo n = 9
Value	-1.6 (-2.3 to 1.1)	-0.7 (-2.6 to 0.4)	-1.5 (-2.1 to 0.5)	-0.3 (-0.7 to 0.2)

Population analysed: All participants had Framingham risk score (FRS) estimated at baseline and month 4. The change from baseline to month 4 was calculated as the outcome.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lisinopril/P-placebo	0 of 10 (0%)	0 of 10 (0%)	Not reported
L-placebo/Pravastatin	0 of 9 (0%)	0 of 10 (0%)	Not reported
Lisinopril/Pravastatin	0 of 9 (0%)	0 of 10 (0%)	Not reported
L-placebo/P-placebo	0 of 9 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): Study was small with limited power to detect differences.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23082133Baker JV, Huppler Hullsiek K, Prosser R, Duprez D, Grimm R, Tracy RP, Rhame F, Henry K, Neaton JD. Angiotensin converting enzyme inhibitor and HMG-CoA reductase inhibitor as adjunct treatment for persons with HIV infection: a feasibility randomized trial. PLoS One. 2012;7(10):e46894. doi: 10.1371/journal.pone.0046894. Epub 2012 Oct 17.

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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.

Jason Baker, MD principal investigator

Hennepin Faculty Associates

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pravastatin and Lisinopril in people with HIV Infection and Cardiovascular Disease Risk, run by Hennepin Healthcare Research Institute at 1 site 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 3 inclusion and 7 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 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Stated (by Self-report) That They Had Side Effects (time frame: 4 months). The study lists 3 primary outcomes in all. 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 NCT00982189, 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 22 Nov 2017.