HIV InfectionsPhase 1NCT00344123
Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects
A Phase 1 study testing Tipranavir/Ritonavir and Rosuvastatin in people with HIV Infections, run by Johns Hopkins University at 1 site in United States.
Trial summary
Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tipranavir/Ritonavir and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have a body mass index (BMI) of 18 to 30 kg/m2, inclusive (BMI = weight (kg)/[height (m)]2) and weigh at least 50 kg.
- Males or females, ages > 18 to < 65 years.
- Women of childbearing potential (WOCBP) must not be nursing or pregnant. All women of childbearing potential (have not reached menopause nor undergone hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum human chorionic gonadotropin (HCG) test performed at screening (within 24 hours before the start of study day 1). Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) or whose male partner has undergone successful vasectomy with resultant azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Documentation of menopause, sterilization (hysterectomy, oophorectomy, tubal ligation, or vasectomy) and azoospermia by patient-reported history is acceptable. Both male and female study volunteers of reproductive potential must agree not to participate in a conception process (i.e., active attempt to become pregnant or to impregnate via sperm donation or in vitro fertilization), and, if participating in sexual activity that could lead to pregnancy, the female study volunteer/male partner must use a form of contraception as specified below while receiving protocol-specified medication(s) and for one month after stopping the medication(s). Male study volunteers will be required to use a barrier method for at least 3 months after completion of the study.
- Condoms (male or female) with or without a spermicidal agent
- Diaphragm or cervical cap with spermicide
Who cannot join
- History or current evidence of any significant acute or chronic medical illness that, within the investigator's discretion, would interfere with the conduct or interpretation of the study.
- History of acute or chronic pancreatitis.
- History of diabetes mellitus, hypertriglyceridemia, or chronic renal insufficiency.
- Proven or suspected acute hepatitis at the time of study entry.
- Current or recent (within 3 months) gastrointestinal disease which would interfere with the conduct or interpretation of the study.
- Any major surgery within 4 weeks of enrollment. Any gastrointestinal surgery that could impact upon the absorption of study drug.
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- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of enrollment.
- Inability to tolerate oral medication.
- Inability to tolerate venipuncture and/or absence of secure venous access.
- Known or suspected HIV infection or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Known active drug or alcohol abuse which, in the opinion of the investigator, makes study participation to completion unlikely.
- Any other sound medical, psychiatric, and/or social reason, as determined by the investigator.
- Subjects with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin above the upper limit of normal.
- Hemoglobin < 9.5 g/dL, and platelet count < 100,000/mm3.
- Subjects with creatine phosphokinase (CPK) elevation greater than 3 times the upper limit of normal.
- Any other clinically significant screening lab abnormality (as determined by the investigator)
- History of any significant drug allergy, drug rash, or sensitivity to any class of drugs relevant to the study drugs.
- Prior exposure to tipranavir/ritonavir.
- Exposure to any investigational drug within 4 weeks of enrollment and throughout the study.
- Any previous hypersensitivity or intolerance to tipranavir or ritonavir or any other ingredient of Aptivus or Norvir.
- Hypersensitivity to sulfonamides
- Any previous hypersensitivity or intolerance to rosuvastatin or any other ingredient of Crestor (rosuvastatin).
- Known elevated liver enzymes in past clinical trials with any compound
- Use of any agent, within 2 weeks of dosing, that is known to induce or inhibit drug metabolizing enzymes
- Use of any over-the-counter drugs, including antacids, alternative herbal products, or prescription drugs that, in the opinion of the investigator, might interfere with the absorption, distribution, or metabolism of TPV, RTV, or rosuvastatin within 14 days of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Evaluation of Single-dose Rosuvastatin 10 mg When Co-administered With Steady-state Tipranavir 500 mg/Ritonavir 200 mg TPV/r) B.I.D. in Healthy Adult Volunteers
Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
Read the detailed description
This is a prospective, open-label pharmacokinetic study in healthy HIV seronegative adults. This study will examine the pharmacokinetic interactions between steady-state TPV/r 500 mg/200 mg B.I.D. and single dose rosuvastatin 10 mg when the drugs are co-administered.
Rosuvastatin 24 hour pharmacokinetic sampling will be performed on days 1-2 and 12-13. Rosuvastatin 48 hr samples will be collected on days 3 and day 14.
Tipranavir and ritonavir 12 hour pharmacokinetic sampling will be on day 11 and 12.
Safety assessments (physical examination, vital sign measurements, and clinical laboratory tests) will be performed at screening, during the study and prior to discharge. Subjects will be continuously monitored for adverse events throughout the duration of the study.
On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500 mg/RTV 200 mg twice daily for 11 days (Days 3-13).
On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r.
- Conditions
- HIV Infections
- Being tested
- Tipranavir/Ritonavir, Rosuvastatin
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tipranavir/RitonavirDrug
Also called Aptivus
On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r.
RosuvastatinDrug
Also called Crestor
On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r..
| Study group | Role | What they receive |
|---|---|---|
| Tipranavir/ritonavir | Other | On Day 1, subjects will receive a single 10 mg dose of rosuvastatin.
Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r. Receives: Drug: Tipranavir/Ritonavir; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare single dose rosuvastatin Area Under the Curve during 24 hours (AUC0-24h) and Cmax with single dose rosuvastatin AUC0-24h and Cmax when co-administered with TPV/r 500 mg/200 mg twice daily at steady state
Measured: 24 hours
Secondary outcomes (1)
To evaluate the short term safety and tolerance of TPV/r (500 mg/200 mg B.I.D) combined with single dose rosuvastatin (10 mg)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startFeb 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Paul Pham, PharmD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344123
- Sponsor's protocol ID
- NA_00003633
- Status last verified
- Feb 2016
- First submitted
- 22 Jun 2006
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is a prospective, open-label pharmacokinetic study
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of Single-dose Rosuvastatin 10 mg When Co-administered With Steady-state Tipranavir 500 mg/Ritonavir 200 mg TPV/r) B.I.D. in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00344123
- Acronym / sponsor ID
- NA_00003633
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Feb 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 Jun 2006 (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.
Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
Detailed description
This is a prospective, open-label pharmacokinetic study in healthy HIV seronegative adults. This study will examine the pharmacokinetic interactions between steady-state TPV/r 500 mg/200 mg B.I.D. and single dose rosuvastatin 10 mg when the drugs are co-administered.
Rosuvastatin 24 hour pharmacokinetic sampling will be performed on days 1-2 and 12-13. Rosuvastatin 48 hr samples will be collected on days 3 and day 14.
Tipranavir and ritonavir 12 hour pharmacokinetic sampling will be on day 11 and 12.
Safety assessments (physical examination, vital sign measurements, and clinical laboratory tests) will be performed at screening, during the study and prior to discharge. Subjects will be continuously monitored for adverse events throughout the duration of the study.
On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500 mg/RTV 200 mg twice daily for 11 days (Days 3-13).
On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tipranavir/ritonavir | Other | Drug: Tipranavir/Ritonavir, Drug: RosuvastatinOn Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13). On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have a body mass index (BMI) of 18 to 30 kg/m2, inclusive (BMI = weight (kg)/[height (m)]2) and weigh at least 50 kg.
- Males or females, ages > 18 to < 65 years.
- Women of childbearing potential (WOCBP) must not be nursing or pregnant. All women of childbearing potential (have not reached menopause nor undergone hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum human chorionic gonadotropin (HCG) test performed at screening (within 24 hours before the start of study day 1). Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) or whose male partner has undergone successful vasectomy with resultant azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Documentation of menopause, sterilization (hysterectomy, oophorectomy, tubal ligation, or vasectomy) and azoospermia by patient-reported history is acceptable. Both male and female study volunteers of reproductive potential must agree not to participate in a conception process (i.e., active attempt to become pregnant or to impregnate via sperm donation or in vitro fertilization), and, if participating in sexual activity that could lead to pregnancy, the female study volunteer/male partner must use a form of contraception as specified below while receiving protocol-specified medication(s) and for one month after stopping the medication(s). Male study volunteers will be required to use a barrier method for at least 3 months after completion of the study.
Key exclusion criteria (25 listed)
- History or current evidence of any significant acute or chronic medical illness that, within the investigator's discretion, would interfere with the conduct or interpretation of the study.
- History of acute or chronic pancreatitis.
- History of diabetes mellitus, hypertriglyceridemia, or chronic renal insufficiency.
- Proven or suspected acute hepatitis at the time of study entry.
- Current or recent (within 3 months) gastrointestinal disease which would interfere with the conduct or interpretation of the study.
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 |
|---|---|---|
| Tipranavir/RitonavirAlso: AptivusOn Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13). On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r. | Drug | Tipranavir/ritonavir |
| RosuvastatinAlso: CrestorOn Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13). On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r.. | Drug | Tipranavir/ritonavir |
Primary outcome
To compare single dose rosuvastatin Area Under the Curve during 24 hours (AUC0-24h) and Cmax with single dose rosuvastatin AUC0-24h and Cmax when co-administered with TPV/r 500 mg/200 mg twice daily at steady state
Time frame: 24 hours
1 secondary outcome
To evaluate the short term safety and tolerance of TPV/r (500 mg/200 mg B.I.D) combined with single dose rosuvastatin (10 mg)
Time frame: 48 hours
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 4 Feb 2016.
- Individual participant dataSharing planned: No. This is a prospective, open-label pharmacokinetic study
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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.
Paul Pham, PharmD principal investigator
Johns Hopkins University
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 Tipranavir/Ritonavir and Rosuvastatin in people with HIV Infections, run by Johns Hopkins University at 1 site in United States.
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 5 inclusion and 25 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 4 Feb 2016. 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 United States. 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?
To compare single dose rosuvastatin Area Under the Curve during 24 hours (AUC0-24h) and Cmax with single dose rosuvastatin AUC0-24h and Cmax when co-administered with TPV/r 500 mg/200 mg twice daily at steady state (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2016.