Status:
WITHDRAWN
Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
FEMALE
16+ years
Brief Summary
This study will evaluate the pharmacokinetic disposition of raltegravir in pregnant HIV-1 infected women. These results will be compared to pharmacokinetic data obtained following pregnancy as well as...
Eligibility Criteria
Inclusion
- Female, 16 years old or older
- Pregnant, at least 14 weeks gestation in order to initiate raltegravir treatment if decided by their pregnancy health care provider. The first pharmacokinetic study visit occurs no sooner than 26 weeks gestation (3rd trimester)
- Normal fetal heart motion by ultrasound, vital signs and brief physical exam as conducted by their primary pregnancy health care provider within two weeks of study entry (part of their standard prenatal care)
- Intolerance or resistance to at least two classes of antiretroviral agents
- Availability of a raltegravir-optimized background regimen based on referring provider's selection and resistance testing
- English or Spanish speaking
Exclusion
- Inability to follow study protocol or drug administration
- Women who are planning to breastfeed (this is not recommended for HIV-infected women to reduce HIV transmission to the baby)
- Women unable to sign informed consent
- Women with a history of anaphylaxis or other life threatening adverse event associated with antiretroviral therapy
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00689910
Start Date
February 1 2008
Last Update
March 29 2012
Active Locations (4)
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1
East Bay AIDS Center
Oakland, California, United States, 94609
2
UC Davis
Sacramento, California, United States, 95817
3
San Francisco General Hospital
San Francisco, California, United States, 94110
4
UC San Francisco
San Francisco, California, United States, 94110