HIV InfectionsPhase 2NCT00184951
Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
A Phase 2 study testing Rosuvastatin in people with HIV Infections and Hyperlipidemia, run by Radboud University Medical Center at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Hyperlipidemia
- What is being tested?
- Rosuvastatin
- How many people
- 30 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Apr 2004to Jul 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- use of lopinavir 400mg/ritonavir 100mg bid > 3months
- HIV-1 RNA <400cop/mL
- fasting total cholesterol > 6.2mmol/L
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Netherlands3 sites
University of Amsterdam
Amsterdam
University of Leiden
Leiden
University of Nijmegen
Nijmegen
About this study
Official title: Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA)
open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
Read the 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.
- Conditions
- HIV Infections, Hyperlipidemia
- Being tested
- Rosuvastatin
- Keywords
- HIV
- Medical subject headings
- HIV Infections, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, AstraZeneca
- Investigators
- David M. Burger, Dr, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184951
- Sponsor's protocol ID
- UMCN-AKF 03.01
- Status last verified
- Nov 2020
- First submitted
- 12 Sep 2005
- Last updated
- 12 Nov 2020
- Results posted
- No
Publications
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.
PubMed 18018771
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA)
- ClinicalTrials.gov ID
- NCT00184951
- Acronym / sponsor ID
- UMCN-AKF 03.01
- Conditions
- HIV Infections, Hyperlipidemia
- Keywords
- HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Abbott, AstraZeneca
- Study start
- Apr 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- use of lopinavir 400mg/ritonavir 100mg bid > 3months
- HIV-1 RNA <400cop/mL
- fasting total cholesterol > 6.2mmol/L
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin | Drug | – |
Primary outcome
pharmacokinetics on week 0,4,8 and 12
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Results publication: PubMed 18018771van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Burger, Dr principal investigator
Radboud University Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rosuvastatin in people with HIV Infections and Hyperlipidemia, run by Radboud University Medical Center at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetics on week 0,4,8 and 12. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.