NCT00184951

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

September 12, 2005

Last Update Submit

November 9, 2020

Conditions

HIV InfectionsHyperlipidemia

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics on week 0,4,8 and 12

Secondary Outcomes (2)

  • 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)

Interventions

RosuvastatinDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Bonn

Bonn, Germany

Location

University of Cologne

Cologne, Germany

Location

University of Amsterdam

Amsterdam, Netherlands

Location

University of Leiden

Leiden, Netherlands

Location

University of Nijmegen

Nijmegen, Netherlands

Location

Related Publications (1)

  • van der Lee M, Sankatsing R, Schippers E, Vogel M, Fatkenheuer G, van der Ven A, Kroon F, Rockstroh J, Wyen C, Baumer A, de Groot E, Koopmans P, Stroes E, Reiss P, Burger D. Pharmacokinetics and pharmacodynamics of combined use of lopinavir/ritonavir and rosuvastatin in HIV-infected patients. Antivir Ther. 2007;12(7):1127-32.

    PMID: 18018771RESULT

MeSH Terms

Conditions

HIV InfectionsHyperlipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David M. Burger, Dr

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

April 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

DE(2)NL(3)