HIVNCT01251601
The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
An observational study of HIV and Pregnancy, run by University of North Carolina, Chapel Hill.
Trial summary
The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- What is being tested?
- Pharmacokinetics
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Sep 2011
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited by their HIV clinic providers
Who may be able to join
- HIV Infected
- Pregnant
- At least 18 years of age
- Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum
Who cannot join
- Less than 18 years of age
- Hemoglobin <9 g/dL or Hematocrit <27.3 at screening
About this study
Official title: The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.
- Being tested
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacokineticsOther
Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir in Pregnancy | HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy Receives: Other: Pharmacokinetics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Withdrawn due to inability to recruit eligible participants
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Angela DM Kashuba, PharmD, Principal investigator, UNC Chapel HillKristine B Patterson, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251601
- Sponsor's protocol ID
- 10-1691
- Status last verified
- Jan 2012
- First submitted
- 30 Nov 2010
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
- ClinicalTrials.gov ID
- NCT01251601
- Acronym / sponsor ID
- 10-1691
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to inability to recruit eligible participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Dec 2010 (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 determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir in Pregnancy | – | Other: PharmacokineticsHIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited by their HIV clinic providers
Key inclusion criteria (4 listed)
- HIV Infected
- Pregnant
- At least 18 years of age
- Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Hemoglobin <9 g/dL or Hematocrit <27.3 at screening
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 |
|---|---|---|
| PharmacokineticsUp to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum | Other | Raltegravir in Pregnancy |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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
UNC Chapel Hill
Kristine B Patterson, MD principal investigator
UNC Chapel Hill
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Pregnancy, run by University of North Carolina, Chapel Hill.
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 2 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: withdrawn, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 28 Feb 2024.