HIV InfectionPhase 2HILLCLIMBERNCT02841774
High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV
A Phase 2 study testing Pravastatin and Rosuvastatin in people with HIV Infection and Coronary Heart Disease, run by Matthew Feinstein at 1 site in United States.
Trial summary
HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily) in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV Infection, Coronary Heart Disease
- What is being tested?
- Pravastatin and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jun 2021
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection
- HIV RNA below the lower limit of assay detection within 12 months of study entry
- 1) Documented coronary heart disease (CHD): nonfatal MI, unrecognized MI, unstable angina pectoris, and/or stable angina pectoris, as defined by the American Heart Association Case Definitions for Acute Coronary Heart Disease in Epidemiology and Clinical Research Studies, OR Or (2) Documented 10-year ASCVD risk of 15% or greater based on the ACC/AHA ASCVD Risk Estimator
- Negative serum or urine pregnancy test
- Men and women age 18 to 75 years of age
Who cannot join
- Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
- No coronary heart disease (CHD) and 10-year ASCVD risk <15.0%.
- Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir.
- History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent
- Statin absolute contraindication
- Current use of atorvastatin 20mg daily or greater or rosuvastatin 10mg daily or greater
Show all 15Show fewer
- Chronic kidney disease stage 4 or greater (including dialysis)
- Systolic heart failure with last documented LVEF <35%
- Pregnant or breastfeeding
- Laboratory values obtained within 45 days prior to study entry:
- LDL-c <80 mg/dl while not on statin or LDL-c <60 mg/dl while on statin ALT > 3 x Upper Limit of Normal (ULN) AST > 3 x ULN Creatinine kinase (CK) >3 x ULN (calculated creatinine clearance (CrCl) <50 mL/min, as estimated by the Cockcroft-Gault equation)
- Life expectancy <12 months
- Prior organ transplant
- Active malignancy
- Inflammatory muscle disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With Human Immunodeficiency Virus (HILLCLIMBER)
HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily) in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).
Read the detailed description
HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy versus high-dose statin therapy in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).
All subjects will have an initial 2-week run-in period with pravastatin 40mg daily (Week 0 to 2). Subjects not demonstrating significant toxicity at week 2 will then be randomized to rosuvastatin 20mg (high intensity dose group) versus continuing pravastatin 40mg daily (moderate intensity group) for 12 weeks (Weeks 2 to 14). At week 6, those in the rosuvastatin arm who do not demonstrate significant toxicity and whose LDL-c is >60mg/dl and decreased by less than 25% compared with week 2 will then have doses increased to rosuvastatin 40mg.
- Conditions
- HIV Infection, Coronary Heart Disease
- Being tested
- Pravastatin, Rosuvastatin
- Medical subject headings
- HIV Infections, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
40mg daily (Weeks 2 - 14)
RosuvastatinDrug
Also called CRESTOR
20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK <+1.5 x ULN, and LDL-c is >60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Group | Active comparator | pravastatin 40mg daily for 12 weeks Receives: Drug: Pravastatin |
| High Intensity Group | Experimental | rosuvastatin 20 - 40 mg daily for 12 weeks Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Fasting LDL-cholesterol
Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14
Measured: Week 2 and Week 14
Treatment-emergent Adverse Events
Number of Grade 3 or above adverse events
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2021
- Study completionJun 2021
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Feinstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Feinstein, Northwestern University
- Investigators
- Donald Lloyd-Jones, MD, Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841774
- Sponsor's protocol ID
- CSC01
- Acronym
- HILLCLIMBER
- Status last verified
- Sep 2022
- First submitted
- 14 Jul 2016
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With Human Immunodeficiency Virus (HILLCLIMBER)
- ClinicalTrials.gov ID
- NCT02841774
- Acronym / sponsor ID
- HILLCLIMBER / CSC01
- Conditions
- HIV Infection, Coronary Heart Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Matthew FeinsteinUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Posted 18 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily) in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).
Detailed description
HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy versus high-dose statin therapy in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).
All subjects will have an initial 2-week run-in period with pravastatin 40mg daily (Week 0 to 2). Subjects not demonstrating significant toxicity at week 2 will then be randomized to rosuvastatin 20mg (high intensity dose group) versus continuing pravastatin 40mg daily (moderate intensity group) for 12 weeks (Weeks 2 to 14). At week 6, those in the rosuvastatin arm who do not demonstrate significant toxicity and whose LDL-c is >60mg/dl and decreased by less than 25% compared with week 2 will then have doses increased to rosuvastatin 40mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Group | Active comparator | Drug: Pravastatinpravastatin 40mg daily for 12 weeks |
| High Intensity Group | Experimental | Drug: Rosuvastatinrosuvastatin 20 - 40 mg daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-1 infection
- HIV RNA below the lower limit of assay detection within 12 months of study entry
- 1) Documented coronary heart disease (CHD): nonfatal MI, unrecognized MI, unstable angina pectoris, and/or stable angina pectoris, as defined by the American Heart Association Case Definitions for Acute Coronary Heart Disease in Epidemiology and Clinical Research Studies, OR Or (2) Documented 10-year ASCVD risk of 15% or greater based on the ACC/AHA ASCVD Risk Estimator
- Negative serum or urine pregnancy test
- Men and women age 18 to 75 years of age
Key exclusion criteria (15 listed)
- Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
- No coronary heart disease (CHD) and 10-year ASCVD risk <15.0%.
- Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir.
- History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent
- Statin absolute contraindication
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 |
|---|---|---|
| Pravastatin40mg daily (Weeks 2 - 14) | Drug | Moderate Intensity Group |
| RosuvastatinAlso: CRESTOR20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK <+1.5 x ULN, and LDL-c is >60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily | Drug | High Intensity Group |
Primary outcome
Mean Percent Change in Fasting LDL-cholesterol
Time frame: Week 2 and Week 14
Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14
Treatment-emergent Adverse Events
Time frame: 14 weeks
Number of Grade 3 or above adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Donald Lloyd-Jones, MD study chair
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pravastatin and Rosuvastatin in people with HIV Infection and Coronary Heart Disease, run by Matthew Feinstein 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 5 inclusion and 15 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 18 Oct 2022. 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. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2022). 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?
Mean Percent Change in Fasting LDL-cholesterol (time frame: Week 2 and Week 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2022.