PregnancyPhase 1NCT00766818
The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet
A Phase 1 study testing Kaletra in people with Pregnancy and HIV, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting ~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Kaletra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive
- Pregnant (<22 weeks)
- Currently taking or planning to start Kaletra
- ≥18 years of age
Who cannot join
- Active opportunistic or serious bacterial infection at the time of entry
- Past or present obstetrical complications (including, but not limited to: placentia previa, eclampsia, confirmed birth defects, multiple gestation pregnancies)
- Unable to maintain medication adherence, defined as ≥ 80% of doses taken between visits
- Currently receiving or expected to receive other protease inhibitors in conjunction with Kaletra®
- HIV genotype showing accumulation of protease inhibitor mutations expected to result in virologic failure on Kaletra® OR documented virologic failure on Kaletra®-containing regimen attributable to the Kaletra® component
- Chronic hepatitis B and/or C virus infection
Show all 15Show fewer
- Cushing's Syndrome
- Untreated hypothyroidism or hyperthyroidism
- Serum Creatinine > 1.5 mg/dL
- Amylase 1.5 times ULN and/or abnormal lipase
- Direct or total bilirubin levels > Grade 1
- ALT/AST > Grade 2 (based on the NIH Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events
- Bicarbonate > Grade 2 (DAIDS)
- Hematology > Grade 2 (DAIDS), except for anemia: exclude only women with Hb< 9 g/dL and/or HCT , 27.3% (< 8.5 mg/dL and/or HCT , 25.6% if currently on ZDV) at screening; all subjects with anemia who enroll in the study must be receiving or start hematinics, including iron and folate supplements, immediately upon enrollment and continue until anemia resolves or end of pregnancy. The hematinic supplements may be discontinued at the discretion of the investigator if they consider continuation would not be in the best interest of the subject.
- Receiving the following drugs: astemizole, terfenadine, rifampin, cisapride, ergot derivatives, simvastatin, lovastatin, St. John's wort, pimozide, midazolam, triazolam, carbamezapine, phenobarbital, phenytoin, or dexamethasone
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet: A Longitudinal Investigation in the Second and Third Trimesters Including Empiric Dosage Adjustment
In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting ~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum, then it will return to the standard 2 adult tablets (400/100mg).
- Being tested
- Kaletra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaletraDrug
Also called lopinavir, ritonovir
Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Kaletra Receives: Drug: Kaletra |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma lopinavir (LPV) using standard doses during the second and third trimesters of pregnancy.
Measured: 20-24 weeks, 30weeks, 32 weeks gestation and 8 weeks postpartum
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma LPV between standard doses (400mg/100mg BID) and increased doses (500/125mg BID) of Kaletra® during the third trimester of pregnancy.
Measured: 20-24weeks, 30 weeks, 32 weeks gestation, 8weeks postpartum
Secondary outcomes (1)
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma ritonavir (RTV) using standard doses during the second and third trimesters of pregnancy.
Measured: 20-24weeks, 30weeks, 32weeks gestation, 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Angela DM Kashuba, PharmD, Principal investigator, University of North CarolinaKristine B Patterson, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766818
- Sponsor's protocol ID
- IRB #06-0653
- Status last verified
- May 2011
- First submitted
- 3 Oct 2008
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet: A Longitudinal Investigation in the Second and Third Trimesters Including Empiric Dosage Adjustment
- ClinicalTrials.gov ID
- NCT00766818
- Acronym / sponsor ID
- IRB #06-0653
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Oct 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.
In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting ~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum, then it will return to the standard 2 adult tablets (400/100mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: KaletraKaletra |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV positive
- Pregnant (<22 weeks)
- Currently taking or planning to start Kaletra
- ≥18 years of age
Key exclusion criteria (15 listed)
- Active opportunistic or serious bacterial infection at the time of entry
- Past or present obstetrical complications (including, but not limited to: placentia previa, eclampsia, confirmed birth defects, multiple gestation pregnancies)
- Unable to maintain medication adherence, defined as ≥ 80% of doses taken between visits
- Currently receiving or expected to receive other protease inhibitors in conjunction with Kaletra®
- HIV genotype showing accumulation of protease inhibitor mutations expected to result in virologic failure on Kaletra® OR documented virologic failure on Kaletra®-containing regimen attributable to the Kaletra® component
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 |
|---|---|---|
| KaletraAlso: lopinavir, ritonovirKaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID | Drug | 1 |
Primary outcome
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma lopinavir (LPV) using standard doses during the second and third trimesters of pregnancy.
Time frame: 20-24 weeks, 30weeks, 32 weeks gestation and 8 weeks postpartum
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma LPV between standard doses (400mg/100mg BID) and increased doses (500/125mg BID) of Kaletra® during the third trimester of pregnancy.
Time frame: 20-24weeks, 30 weeks, 32 weeks gestation, 8weeks postpartum
1 secondary outcome
To compare the C12h and AUC0-12h of protein bound and unbound blood plasma ritonavir (RTV) using standard doses during the second and third trimesters of pregnancy.
Time frame: 20-24weeks, 30weeks, 32weeks gestation, 8 weeks postpartum
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 13 May 2011.
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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 DM Kashuba, PharmD principal investigator
University of North Carolina
Kristine B Patterson, MD principal investigator
University of North Carolina
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 Kaletra in people with Pregnancy and HIV, run by University of North Carolina, Chapel Hill 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 4 inclusion and 15 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 13 May 2011. 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 the C12h and AUC0-12h of protein bound and unbound blood plasma lopinavir (LPV) using standard doses during the second and third trimesters of pregnancy. (time frame: 20-24 weeks, 30weeks, 32 weeks gestation and 8 weeks postpartum). 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 13 May 2011.