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Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689910
Recruitment Status : Withdrawn
First Posted : June 4, 2008
Last Update Posted : March 29, 2012
Merck Sharp & Dohme Corp.
Information provided by:
University of California, San Francisco

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 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 or disease
HIV Infections

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum
Study Start Date : February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Raltegravir

Biospecimen Retention:   Samples Without DNA
Plasma Cervicovaginal lavage fluid Endocervical canal fluid

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00689910

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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
Sponsors and Collaborators
University of California, San Francisco
Merck Sharp & Dohme Corp.
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Responsible Party: Francesca Aweeka, University of California, San Francisco Identifier: NCT00689910    
Other Study ID Numbers: PK of Ral in Pregnant Women
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Keywords provided by University of California, San Francisco:
Treatment of HIV in pregnant women with Raltegravir
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases