HIV InfectionsPhase 1GRAPPANCT00665717
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
A Phase 1 study testing Pravastatin, Raltegravir and Pravastatin and raltegravir in people with HIV Infections, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Pravastatin, Raltegravir and Pravastatin and raltegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2008to Oct 2008
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is at least 18 and not older than 55 years of age.
- Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.
- Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Subject is in good age-appropriate health condition.
- Subject has a normal blood pressure and pulse rate.
Who cannot join
- Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.
- Positive HIV test.
- Positive hepatitis B or C test.
- Pregnant female or breast-feeding female.
- Therapy with any drug.
- Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
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- Fasting triglyceride levels > 8.0 mmol/L
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- History of or current abuse of drugs, alcohol or solvents.
- Inability to understand the nature and extent of the trial and the procedures required.
- Participation in a drug trial within 60 days prior to the first dose.
- Donation of blood within 60 days prior to the first dose.
- Febrile illness within 3 days before the first dose
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland
About this study
Official title: The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA)
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.
Read the detailed description
Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction.
Because co-administration will be indicated in many HIV-infected patients, it is essential to investigate this potential interaction.
- Conditions
- HIV Infections
- Being tested
- Pravastatin, Raltegravir, Pravastatin and raltegravir
- Keywords
- interaction, statins, pharmacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
Also called Selektine
40 mg tablet; QD; 4 days
RaltegravirDrug
Also called Isentress
400mg tablet; BD 4 days
Pravastatin and raltegravirDrug
Also called Selektine and Isentress
pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Pravastatin 40 mg QD for 4 days Receives: Drug: Pravastatin |
| B | Active comparator | Raltegravir 400mg BD for 4 days Receives: Drug: Raltegravir |
| C | Experimental | Interaction between pravastatin and raltegravir Receives: Drug: Pravastatin and raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of pravastatin and raltegravir.
Measured: t=0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and (24: for pravastatin only) hours post ingestion on Days 4, 18 and 32. Trough level on Day 2, 16 and 30.
Secondary outcomes (3)
To investigate the non-steady state changes in serum low density lipoprotein (LDL) cholesterol secondary to pravastatin use in the presence or absence of raltegravir
Measured: Screening and Days 1, 5, 15, 19, 29 and 33.
Determination of pharmacokinetic parameters
Measured: at each sampling time
To evaluate the safety of combined use of pravastatin and raltegravir
Measured: entire trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2008
- Study completionOct 2008
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- David M Burger, PharmD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665717
- Sponsor's protocol ID
- UMCN-AKF 07.05
- Acronym
- GRAPPA
- Status last verified
- May 2011
- First submitted
- 23 Apr 2008
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
van Luin M, Colbers A, van Ewijk-Beneken Kolmer EW, Verweij-van Wissen CP, Schouwenberg B, Hoitsma A, da Silva HG, Burger DM. Drug-drug interactions between raltegravir and pravastatin in healthy volunteers. J Acquir Immune Defic Syndr. 2010 Sep;55(1):82-6. doi: 10.1097/QAI.0b013e3181d9a354.
PubMed 20395869
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA)
- ClinicalTrials.gov ID
- NCT00665717
- Acronym / sponsor ID
- GRAPPA / UMCN-AKF 07.05
- Conditions
- HIV Infections
- Keywords
- interaction, statins, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Apr 2008 (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.
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.
Detailed description
Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction.
Because co-administration will be indicated in many HIV-infected patients, it is essential to investigate this potential interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: PravastatinPravastatin 40 mg QD for 4 days |
| B | Active comparator | Drug: RaltegravirRaltegravir 400mg BD for 4 days |
| C | Experimental | Drug: Pravastatin and raltegravirInteraction between pravastatin and raltegravir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is at least 18 and not older than 55 years of age.
- Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.
- Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Subject is in good age-appropriate health condition.
Key exclusion criteria (13 listed)
- Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.
- Positive HIV test.
- Positive hepatitis B or C test.
- Pregnant female or breast-feeding female.
- Therapy with any drug.
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 |
|---|---|---|
| PravastatinAlso: Selektine40 mg tablet; QD; 4 days | Drug | A |
| RaltegravirAlso: Isentress400mg tablet; BD 4 days | Drug | B |
| Pravastatin and raltegravirAlso: Selektine and Isentresspravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days | Drug | C |
Primary outcome
Plasma concentrations of pravastatin and raltegravir.
Time frame: t=0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and (24: for pravastatin only) hours post ingestion on Days 4, 18 and 32. Trough level on Day 2, 16 and 30.
3 secondary outcomes
To investigate the non-steady state changes in serum low density lipoprotein (LDL) cholesterol secondary to pravastatin use in the presence or absence of raltegravir
Time frame: Screening and Days 1, 5, 15, 19, 29 and 33.
Determination of pharmacokinetic parameters
Time frame: at each sampling time
To evaluate the safety of combined use of pravastatin and raltegravir
Time frame: entire trial
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 19 Oct 2020.
- Results publication: PubMed 20395869van Luin M, Colbers A, van Ewijk-Beneken Kolmer EW, Verweij-van Wissen CP, Schouwenberg B, Hoitsma A, da Silva HG, Burger DM. Drug-drug interactions between raltegravir and pravastatin in healthy volunteers. J Acquir Immune Defic Syndr. 2010 Sep;55(1):82-6. doi: 10.1097/QAI.0b013e3181d9a354.
- Publication in Journal of Acquired Immune Deficiency Syndromes; Issue: Volume 55(1), 1 September 2010, pp 82-86Link provided by the sponsor.
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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, PharmD PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pravastatin, Raltegravir and Pravastatin and raltegravir in people with HIV Infections, run by Radboud University Medical Center at 1 site in Netherlands.
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 6 inclusion and 13 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Plasma concentrations of pravastatin and raltegravir. (time frame: t=0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and (24: for pravastatin only) hours post ingestion on Days 4, 18 and 32. Trough level on Day 2, 16 and 30.). 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 NCT00665717, 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 19 Oct 2020.