The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
This study has been withdrawn prior to enrollment.
(Withdrawn due to inability to recruit eligible participants)
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Angela Kashuba, PharmD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01251601
First received: November 30, 2010
Last updated: January 31, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Pregnancy |
Other: Pharmacokinetics |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
| Enrollment: | 0 |
| Study Start Date: | November 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Raltegravir in Pregnancy
HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy
|
Other: Pharmacokinetics
Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients will be recruited by their HIV clinic providers
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Less than 18 years of age
- Hemoglobin <9 g/dL or Hematocrit <27.3 at screening
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251601
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251601
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Investigators
| Principal Investigator: | Angela DM Kashuba, PharmD | UNC Chapel Hill | |
| Principal Investigator: | Kristine B Patterson, MD | UNC Chapel Hill |
More Information
No publications provided
| Responsible Party: | Angela Kashuba, PharmD, Professor, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01251601 History of Changes |
| Other Study ID Numbers: | 10-1691 |
| Study First Received: | November 30, 2010 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on March 02, 2015