HIVPhase 1NCT00743470
A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
A Phase 1 study testing lopinavir/ritonavir and rifabutin in people with HIV and Tuberculosis, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Tuberculosis
- What is being tested?
- lopinavir/ritonavir and rifabutin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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
- Adult Male or Female 18-55 yrs.
- Subject has provided written consent.
- Subject is in general good health.
- If female, subject is postmenopausal.
- If female, subject is not pregnant and is not breast-feeding.
- Subject must use birth control methods or be surgically sterile.
Who cannot join
- Subject is HAV-IgM, HBsAg or HIV Ab positive.
- Positive screen for drugs of abuse, alcohol, or smoking.
- Cannot be on any medication, including over the counter drugs.
- Cannot have previous history of alcohol or drug abuse.
- Cannot have history of any major diseases or disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 11441
Waukegan, Illinois, 60085
About this study
Official title: A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects
The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.
- Conditions
- HIV, Tuberculosis
- Being tested
- lopinavir/ritonavir, rifabutin
- Keywords
- HIV co-infected with tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lopinavir/ritonavirDrug
Also called ABT-378, Kaletra
lopinavir/ritonavir tablet; see arm for intervention description
rifabutinDrug
rifabutin capsule; see arms for intervention description
| Study group | Role | What they receive |
|---|---|---|
| A, B | Experimental | Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID. Receives: Drug: lopinavir/ritonavir; Drug: rifabutin |
| C | Experimental | Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID. Receives: Drug: lopinavir/ritonavir; Drug: rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.
Measured: Approximately 0.5 - 1 month
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Measured: Approximately 0.5 - 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Angela Nilius, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743470
- Sponsor's protocol ID
- M10-457
- Status last verified
- Sep 2010
- First submitted
- 27 Aug 2008
- Last updated
- 2 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00743470
- Acronym / sponsor ID
- M10-457
- Conditions
- HIV, Tuberculosis
- Keywords
- HIV co-infected with tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- First posted
- 28 Aug 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 study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, B | Experimental | Drug: lopinavir/ritonavir, Drug: rifabutinGroup 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID. |
| C | Experimental | Drug: lopinavir/ritonavir, Drug: rifabutinGroup 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult Male or Female 18-55 yrs.
- Subject has provided written consent.
- Subject is in general good health.
- If female, subject is postmenopausal.
- If female, subject is not pregnant and is not breast-feeding.
Key exclusion criteria (5 listed)
- Subject is HAV-IgM, HBsAg or HIV Ab positive.
- Positive screen for drugs of abuse, alcohol, or smoking.
- Cannot be on any medication, including over the counter drugs.
- Cannot have previous history of alcohol or drug abuse.
- Cannot have history of any major diseases or disorders.
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 |
|---|---|---|
| lopinavir/ritonavirAlso: ABT-378, Kaletralopinavir/ritonavir tablet; see arm for intervention description | Drug | A, B, C |
| rifabutinrifabutin capsule; see arms for intervention description | Drug | A, B, C |
Primary outcome
Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.
Time frame: Approximately 0.5 - 1 month
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Time frame: Approximately 0.5 - 1 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
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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.
Angela Nilius, MD study director
Abbott
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 lopinavir/ritonavir and rifabutin in people with HIV and Tuberculosis, run by Abbott 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Nov 2010. 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 was stopped early. Results are not available in the source record.
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?
Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter. (time frame: Approximately 0.5 - 1 month). The study lists 2 primary outcomes in all. 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 2 Nov 2010.