Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum
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Purpose
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 to studies previously carried out in nonpregnant women and male patients. By determining the disposition characteristics for this specific patient population, antiretroviral (ARV) dosing can be optimized during pregnancy. Appropriate dosing is necessary to minimize adverse effects, slow progression of disease, and further reduce the risk for vertical transmission. Data will also be obtained on genital tract penetration and placenta transfer of raltegravir to the newborn.
The subjects enrolled in this study will take an antiretroviral based regimen containing raltegravir twice daily both during and after their pregnancy. The specific regimen will be chosen by their own primary care provider based on their antiretroviral history and resistance testing. They will undergo a series of blood sampling for pharmacokinetic analysis over 12 hours on two occasions; a) during their 3rd trimester and b) approximately 3 months postpartum. Concentrations of raltegravir in the infant will be assessed by cord and infant blood sample at delivery and a blood sample at approximately 3 months of age.
Hypothesis: The pharmacokinetic exposure of raltegravir as measured by the 12 hour area under the plasma concentration versus time curve (AUC0-12h) during third trimester pregnancy is similar to the AUC0-12h estimated three months post-partum.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Preliminary eligibility will be determined by the study investigators, research staff, and the patient's primary pregnancy healthcare provider. During a dedicated visit to the primary investigator's office, potential participants will undergo a screening examination including review of physical exam and blood work obtained by their primary pregnancy provider within two weeks of study enrollment. Those that qualify will then provide written consent and be able to continue in the study.
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| United States, California | |
| East Bay AIDS Center | |
| Oakland, California, United States, 94609 | |
| UC Davis | |
| Sacramento, California, United States, 95817 | |
| San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
| UC San Francisco | |
| San Francisco, California, United States, 94110 | |
More Information
No publications provided
| Responsible Party: | Francesca Aweeka, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00689910 History of Changes |
| Other Study ID Numbers: | PK of Ral in Pregnant Women |
| Study First Received: | June 2, 2008 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
pharmacokinetics pregnancy Raltegravir |
HIV antiretroviral Treatment of HIV in pregnant women with Raltegravir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013
