HealthyPhase 1NCT00809718
The Effect of Rifapentine on Raltegravir
A Phase 1 study testing Raltegravir and rifapentine in people with Healthy, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Raltegravir and rifapentine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Aug 2011
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-nursing female age > 18 years in good health
- Provision of informed consent for the study.
- HIV-uninfected. A prior negative HIV test (ELISA) must be obtained before enrollment.
- Willingness to have PK sampling in a day clinic or to be admitted overnight to a hospital on three occasions.
- Women of child-bearing potential must agree to practice an adequate method of birth control during the study and for 30 days after the last dose of study medication. Barrier methods of contraception or abstinence from sexual activity are satisfactory methods of birth control.
- Karnofsky score ≥ 90.
Show all 13Show fewer
- Laboratory screening before enrollment:
- Hematocrit > 30 percent (most recent value)
- AST < 2 times the upper limit of normal
- ALT < 2 times the upper limit of normal
- Bilirubin < 2 times the upper limit of normal
- Creatinine < 1.5 times the upper limit of normal
- Negative urine drug screen
Who cannot join
- Pregnancy or breast-feeding.
- Use of a medication or food that has the potential to alter the concentrations of raltegravir or rifapentine, within the 14 days prior to or during the periods of pharmacokinetic monitoring.
- Known intolerance to raltegravir or rifamycin antibiotics or prior use in the last 30 days.
- Weight less than 46 kg or greater than 102 kg.
- Prior gastrointestinal surgery.
- Infection with Hepatitis B or Hepatitis C by serologies.
- Co-morbidity for which concomitant, current medications are taken regularly. If concomitant medications are taken intermittently, these medications should not have potential to alter the concentrations of raltegravir or rifapentine.
- Current imprisonment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Audie L Murphy Veterans Administration Hospital
San Antonio, Texas, 78229
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: The Effect of Rifapentine on Plasma Concentrations of Raltegravir
The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.
Read the detailed description
Primary Objective
To compare the pharmacokinetics parameter values (geometric mean Cmin and AUC) of raltegravir at 400 mg q12h alone to raltegravir at 400 mg q12h co-administered in combination with rifapentine 900 mg once weekly, and to raltegravir at 400 mg q12h co-administered in combination with rifapentine 600 mg per day, 5 days per week.
Secondary Objective
To assess the tolerability and safety of concomitant administration of raltegravir and rifapentine in healthy volunteers.
Design
This study is a three-period, one-sequence, open label, pharmacokinetic study of the raltegravir-rifapentine interactions in healthy, male and female volunteers. Up to 21 subjects may be enrolled to achieve the estimated sample size of 16 completing subjects. All study medication will be self-administered except on the days of pharmacokinetic sampling. All subjects will participate in three sampling periods and be studied in a day clinic or be admitted overnight to a hospital.
- Conditions
- Healthy
- Being tested
- Raltegravir and rifapentine
- Keywords
- Raltegravir, Pharmacokinetics, Rifapentine, Drug Kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir and rifapentineDrug
Also called Isentress - Raltegravir, Priftin - Rifapentine
Period 1- Raltegravir 400 mg q12h by mouth for 4 days
Period 2- Rifapentine 900 mg taken by mouth once per week for 3 doses and raltegravir 400 mg q12h by mouth for 4 days
Period 3- Rifapentine 600 mg taken by mouth once daily for 5 of 7 days per week for 10 doses and raltegravir 400 mg q12h by mouth for 4 days
| Study group | Role | What they receive |
|---|---|---|
| raltegravir and rifapentine | Other | Concomitant administration of raltegravir and rifapentine in healthy volunteers Receives: Drug: Raltegravir and rifapentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raltegravir pharmacokinetics (Cmin and AUC)
Measured: Eight weeks
Secondary outcomes (1)
Tolerability and safety of concomitant raltegravir and rifapentine administration
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionAug 2011
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 HealthyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Centers for Disease Control and Prevention, VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Marc Weiner, M.D., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809718
- Sponsor's protocol ID
- TBTC 29RR
- Status last verified
- Oct 2015
- First submitted
- 15 Dec 2008
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weiner M, Egelund EF, Engle M, Kiser M, Prihoda TJ, Gelfond JA, Mac Kenzie W, Peloquin CA. Pharmacokinetic interaction of rifapentine and raltegravir in healthy volunteers. J Antimicrob Chemother. 2014 Apr;69(4):1079-85. doi: 10.1093/jac/dkt483. Epub 2013 Dec 15.
PubMed 24343893
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rifapentine on Plasma Concentrations of Raltegravir
- ClinicalTrials.gov ID
- NCT00809718
- Acronym / sponsor ID
- TBTC 29RR
- Conditions
- Healthy
- Keywords
- Raltegravir, Pharmacokinetics, Rifapentine, Drug Kinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Centers for Disease Control and Prevention, VA Office of Research and Development
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Dec 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 aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.
Detailed description
Primary Objective
To compare the pharmacokinetics parameter values (geometric mean Cmin and AUC) of raltegravir at 400 mg q12h alone to raltegravir at 400 mg q12h co-administered in combination with rifapentine 900 mg once weekly, and to raltegravir at 400 mg q12h co-administered in combination with rifapentine 600 mg per day, 5 days per week.
Secondary Objective
To assess the tolerability and safety of concomitant administration of raltegravir and rifapentine in healthy volunteers.
Design
This study is a three-period, one-sequence, open label, pharmacokinetic study of the raltegravir-rifapentine interactions in healthy, male and female volunteers. Up to 21 subjects may be enrolled to achieve the estimated sample size of 16 completing subjects. All study medication will be self-administered except on the days of pharmacokinetic sampling. All subjects will participate in three sampling periods and be studied in a day clinic or be admitted overnight to a hospital.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| raltegravir and rifapentine | Other | Drug: Raltegravir and rifapentineConcomitant administration of raltegravir and rifapentine in healthy volunteers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or non-pregnant, non-nursing female age > 18 years in good health
- Provision of informed consent for the study.
- HIV-uninfected. A prior negative HIV test (ELISA) must be obtained before enrollment.
- Willingness to have PK sampling in a day clinic or to be admitted overnight to a hospital on three occasions.
- Women of child-bearing potential must agree to practice an adequate method of birth control during the study and for 30 days after the last dose of study medication. Barrier methods of contraception or abstinence from sexual activity are satisfactory methods of birth control.
Key exclusion criteria (8 listed)
- Pregnancy or breast-feeding.
- Use of a medication or food that has the potential to alter the concentrations of raltegravir or rifapentine, within the 14 days prior to or during the periods of pharmacokinetic monitoring.
- Known intolerance to raltegravir or rifamycin antibiotics or prior use in the last 30 days.
- Weight less than 46 kg or greater than 102 kg.
- Prior gastrointestinal surgery.
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 |
|---|---|---|
| Raltegravir and rifapentineAlso: Isentress - Raltegravir, Priftin - RifapentinePeriod 1- Raltegravir 400 mg q12h by mouth for 4 days Period 2- Rifapentine 900 mg taken by mouth once per week for 3 doses and raltegravir 400 mg q12h by mouth for 4 days Period 3- Rifapentine 600 mg taken by mouth once daily for 5 of 7 days per week for 10 doses and raltegravir 400 mg q12h by mouth for 4 days | Drug | raltegravir and rifapentine |
Primary outcome
Raltegravir pharmacokinetics (Cmin and AUC)
Time frame: Eight weeks
1 secondary outcome
Tolerability and safety of concomitant raltegravir and rifapentine administration
Time frame: Eight weeks
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 22 Oct 2015.
- Derived from this study: PubMed 24343893Weiner M, Egelund EF, Engle M, Kiser M, Prihoda TJ, Gelfond JA, Mac Kenzie W, Peloquin CA. Pharmacokinetic interaction of rifapentine and raltegravir in healthy volunteers. J Antimicrob Chemother. 2014 Apr;69(4):1079-85. doi: 10.1093/jac/dkt483. Epub 2013 Dec 15.
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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.
Marc Weiner, M.D. principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Raltegravir and rifapentine in people with Healthy, run by The University of Texas Health Science Center at San Antonio at 2 sites 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 13 inclusion and 8 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 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Raltegravir pharmacokinetics (Cmin and AUC) (time frame: Eight weeks). 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 NCT00809718, 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 22 Oct 2015.