NCT01935674

Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels

Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Juan A. Arnaiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.

Detailed description

To compare the effects of rosuvastatin to protease inhibitor switching on: * Total cholesterol through week 12 * Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy) * Quality of life (SF-12) * Fasting LDL cholesterol (estimated with Friedewald equation unless triglycerides \>400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides * Fasting glucose and insulin * Framingham cardiovascular risk score * D:A:D 5-year estimated risk calculator

Conditions

• HIV
• Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	Switch ritonavir-boosted PI	Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
DRUG	Continue Ritonavir-boosted PI+Rosuvastatin	Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-09-05
• Last updated: 2025-07-16
• Results posted: 2025-07-16

Locations

1 site across 1 country: Spain