The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
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ClinicalTrials.gov Identifier: NCT01251601 |
Recruitment Status
:
Withdrawn
(Withdrawn due to inability to recruit eligible participants)
First Posted
: December 2, 2010
Last Update Posted
: February 2, 2012
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Condition or disease | Intervention/treatment |
---|---|
HIV Pregnancy | Other: Pharmacokinetics |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Time Perspective: | Prospective |
Official Title: | The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |
Group/Cohort | Intervention/treatment |
---|---|
Raltegravir in Pregnancy
HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy
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Other: Pharmacokinetics
Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum
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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251601
Principal Investigator: | Angela DM Kashuba, PharmD | UNC Chapel Hill | |
Principal Investigator: | Kristine B Patterson, MD | UNC Chapel Hill |
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 |
First Posted: | December 2, 2010 Key Record Dates |
Last Update Posted: | February 2, 2012 |
Last Verified: | January 2012 |
Additional relevant MeSH terms:
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |