| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02344290 | Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults | PHASE3 | COMPLETED | 7,769 | — | — | Mar 26, 2015 | Aug 21, 2023 | Sep 4, 2025 | 137 | United States, Botswana +11 |
MACE is a composite of cardiovascular (CV) death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack (TIA), peripheral arterial ischemia, coronary, carotid or peripheral arterial revascularization, or death from an undetermined cause. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy).
| Arm | Type | Description |
|---|---|---|
| Pitavastatin | EXPERIMENTAL | Participants received pitavastatin once a day for the entire time they were in study follow-up. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo for pitavastatin once a day for the entire time they were in study follow-up. |
| Name | Type | Description |
|---|---|---|
| Pitavastatin | DRUG | One tablet (4 mg) taken once daily, orally with or without food |
| Placebo | DRUG | One tablet taken once daily, orally with or without food |
Inclusion Criteria: * Individual with HIV-1 * Combination antiretroviral therapy (ART) for at least 180 days prior to study entry * CD4+ cell count greater than 100 cells/mm\^3 * Acceptable screening laboratories including: * Fasting low-density lipoprotein (LDL) cholesterol as follows: * I...