Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184951

Enrollment

Registered

2005-09-16

Start date

2004-04-30

Completion date

2005-07-31

Last updated

2020-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Hyperlipidemia

Keywords

HIV

Brief summary

open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.

Detailed description

To determine the effect of rosuvastatin on plasma lipids, lipoproteins, and endothelial function in HIV-infected patients on stable lopinavir/ritonavir therapy and to evaluate the safety of combined use of rosuvastatin and lopinavir/ritonavir. Also to determine the effect of lopinavir/ritonavir on the pharmacokinetics of rosuvastatin compared to historical controls an to determine the effect of rosuvastatin on the pk of lopinavir/ritonavir compared to historical controls and by intrapatient comparison.

Interventions

DRUGRosuvastatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* use of lopinavir 400mg/ritonavir 100mg bid \> 3months * HIV-1 RNA \<400cop/mL * fasting total cholesterol \> 6.2mmol/L

Exclusion criteria

* history of sensitivity/idiosyncrasy to the drug or compounds used * history or current condition that might interfere with absorption,distribution metabolism or excretion * pregnant or breast-feeding * serum transaminase levels \>3 times upper limit of normal, creatinine clearance \<60ml/min * fasting plasma triglycerides level \>8.0 mmol/L * history of statin-related rhabdomyolysis or inheritable muscle diseases in family history * clinical symptoms of myopathy or abnormal CK level * change in antiretroviral medication within the 3 months immediately preceding first dose of rosuvastatin * use of any statin or fibrate within 6 weeks immediately preceding first dose of rosuvastatin * concomitant use of medications that interfere with rosuvastatin or lopinavir pharmacokinetics * active hepatobiliary or hepatic disease * hypothyroidism * alcohol abuse * japanese or chinese patients

Design outcomes

Primary

Measure	Time frame
pharmacokinetics on week 0,4,8 and 12	—

Secondary

Measure	Time frame
evaluation of lipid lowering activity on week 0,4,8,12	—
endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen)	—

Countries

Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026