HIV InfectionPhase 4NCT00420355
Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients
A Phase 4 study testing atazanavir and lopinavir/ritonavir in people with HIV Infection, run by University of Oklahoma at 1 site in United States.
Trial summary
The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- atazanavir and lopinavir/ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2008
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-seropositive
- Currently receiving atazanavir/ritonavir or lopinavir/ritonavir in combination with 2-3 nucleoside RT inhibitors or are antiretroviral treatment-naïve
- If female, is not of childbearing potential or is of childbearing potential and agrees to use a barrier method of contraception throughout the study
Who cannot join
- HIV-1 RNA > 400 copies/mL if currently receiving antiretroviral therapy
- Concurrent use of CYP450 inhibitors or inducers
- Concurrent use of P-glycoprotein substrates, inhibitors, or inducers
- Concurrent use of medications known to interact with ritonavir or atazanavir
- Presence of a chronic health condition deemed by the investigators to potentially impair lopinavir, ritonavir, or atazanavir pharmacokinetics
- Presence of conduction abnormalities on electrocardiogram
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- Women who are pregnant or breastfeeding
- Laboratory Abnormalities at baseline:
- Aminotransferases > 3x ULN
- Serum bilirubin > 5x ULN
- Serum creatinine > 1.5x ULN
- Hemoglobin concentration < 8.0 g/dL
- Absolute neutrophil count < 800 cells/μL
- Platelet count < 50,000 cells/μL
Trial locations and contacts
1 site in 1 country.
United States1 site
OUHSC General Clinical Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects
The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.
Read the detailed description
Thirty patients with HIV infection will be enrolled in this open-label, parallel arm pharmacokinetic study. Subjects receiving either lopinavir/ritonavir or atazanavir/ritonavir as part of their antiretroviral therapy will have a pharmacokinetic study performed over 12-20 days to examine whether coadministration of lopinavir and atazanavir alters the pharmacokinetics of either agent. The safety of these agents in combination will also be explored.
- Conditions
- HIV Infection
- Being tested
- atazanavir, lopinavir/ritonavir
- Keywords
- antiretroviral therapy, protease inhibitors, drug interactions, HIV infection, acquired immunodeficiency syndrome, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atazanavirDrug
Also called Reyataz 300 mg capsules
Atazanavir 300 mg daily on Days 6-12.
lopinavir/ritonavirDrug
Also called Kaletra 200 mg/50 mg tablets
Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Subjects on atazanavir/ritonavir will add lopinavir/ritonavir. Receives: Drug: lopinavir/ritonavir |
| Arm B | Experimental | Subjects on lopinavir/ritonavir will add atazanavir. Receives: Drug: atazanavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir
Measured: Day 6, Day 12 or 16, Day 20
Secondary outcomes (1)
Safety (e.g., GI tolerance, lab abnormalities, ECG changes)
Measured: Day 6, Day 12 or Day 16, Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionSep 2008
Why it stopped: Unexpected adverse event
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 InfectionStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- R. Chris Rathbun, Pharm.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420355
- Sponsor's protocol ID
- 12637
- Status last verified
- Feb 2009
- First submitted
- 9 Jan 2007
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rathbun CR, Liedtke MD, Blevins SM, Harrison D, Lockhart SM, Salvaggio M, Acosta EP. Electrocardiogram abnormalities with atazanavir and lopinavir/ritonavir. HIV Clin Trials. 2009 Sep-Oct;10(5):328-36. doi: 10.1310/hct1005-328.
PubMed 19906626
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00420355
- Acronym / sponsor ID
- 12637
- Conditions
- HIV Infection
- Keywords
- antiretroviral therapy, protease inhibitors, drug interactions, HIV infection, acquired immunodeficiency syndrome, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unexpected adverse event
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Jan 2007 (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 objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.
Detailed description
Thirty patients with HIV infection will be enrolled in this open-label, parallel arm pharmacokinetic study. Subjects receiving either lopinavir/ritonavir or atazanavir/ritonavir as part of their antiretroviral therapy will have a pharmacokinetic study performed over 12-20 days to examine whether coadministration of lopinavir and atazanavir alters the pharmacokinetics of either agent. The safety of these agents in combination will also be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: lopinavir/ritonavirSubjects on atazanavir/ritonavir will add lopinavir/ritonavir. |
| Arm B | Experimental | Drug: atazanavirSubjects on lopinavir/ritonavir will add atazanavir. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HIV-seropositive
- Currently receiving atazanavir/ritonavir or lopinavir/ritonavir in combination with 2-3 nucleoside RT inhibitors or are antiretroviral treatment-naïve
- If female, is not of childbearing potential or is of childbearing potential and agrees to use a barrier method of contraception throughout the study
Key exclusion criteria (14 listed)
- HIV-1 RNA > 400 copies/mL if currently receiving antiretroviral therapy
- Concurrent use of CYP450 inhibitors or inducers
- Concurrent use of P-glycoprotein substrates, inhibitors, or inducers
- Concurrent use of medications known to interact with ritonavir or atazanavir
- Presence of a chronic health condition deemed by the investigators to potentially impair lopinavir, ritonavir, or atazanavir pharmacokinetics
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 |
|---|---|---|
| atazanavirAlso: Reyataz 300 mg capsulesAtazanavir 300 mg daily on Days 6-12. | Drug | Arm B |
| lopinavir/ritonavirAlso: Kaletra 200 mg/50 mg tabletsLopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21. | Drug | Arm A |
Primary outcome
Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir
Time frame: Day 6, Day 12 or 16, Day 20
1 secondary outcome
Safety (e.g., GI tolerance, lab abnormalities, ECG changes)
Time frame: Day 6, Day 12 or Day 16, Day 20
Results and safety
The study was stopped early (reason given: Unexpected adverse event). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
- Derived from this study: PubMed 19906626Rathbun CR, Liedtke MD, Blevins SM, Harrison D, Lockhart SM, Salvaggio M, Acosta EP. Electrocardiogram abnormalities with atazanavir and lopinavir/ritonavir. HIV Clin Trials. 2009 Sep-Oct;10(5):328-36. doi: 10.1310/hct1005-328.
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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.
R. Chris Rathbun, Pharm.D. principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atazanavir and lopinavir/ritonavir in people with HIV Infection, run by University of Oklahoma 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 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: stopped early, as of the sponsor's last update on 6 Feb 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (reason given: Unexpected adverse event). 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?
Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir (time frame: Day 6, Day 12 or 16, Day 20). 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 NCT00420355, 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 6 Feb 2009.