A Phase 2 interventional study of Pravastatin and Rosuvastatin in HIV Infection and Coronary Heart Disease, sponsored by Matthew Feinstein. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-18.
Sponsored by Matthew Feinstein · Phase 2, Interventional, and Treatment
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).
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →This is the only study on the registry with Matthew Feinstein as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
pravastatin 40mg daily for 12 weeks
Drug: Pravastatin
rosuvastatin 20 - 40 mg daily for 12 weeks
Drug: Rosuvastatin
40mg daily (Weeks 2 - 14)
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
Also known as: CRESTOR
Mean Percent Change in Fasting LDL-cholesterol
Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14
Time frame: Week 2 and Week 14
Treatment-emergent Adverse Events
Number of Grade 3 or above adverse events
Time frame: 14 weeks
| Milestone | Moderate Intensity Group | High Intensity Group |
|---|---|---|
| Started | 6 | 4 |
| Completed | 6 | 4 |
| Not completed | 0 | 0 |
Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14
| Percent decrease | Moderate Intensity Group | High Intensity Group |
|---|---|---|
| Mean Percent Change in Fasting LDL-cholesterol | 15.0 (-9.0 to 30.1) | 41.6 (35.7 to 47.7) |
Number of Grade 3 or above adverse events
| Participants | Moderate Intensity Group | High Intensity Group |
|---|---|---|
| Treatment-emergent Adverse Events | 0 | 0 |
Collected over Up to 20 weeks, from the time of screening to completion (week 14). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate Intensity Group | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| High Intensity Group | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Moderate Intensity Group | High Intensity Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 2 | 6 |
| >=65 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Moderate Intensity Group | High Intensity Group | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 6 | 3 | 9 |
| Race (NIH/OMB)(Participants) | Moderate Intensity Group | High Intensity Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Moderate Intensity Group | High Intensity Group | Total |
|---|---|---|---|
| United States | 6 | 4 | 10 |
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