A Study of the Pharmacology of Tamiflu in Pregnancy

NCT ID: NCT01203527

Last Updated: 2013-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-10-31

Brief Summary

The purpose of this study is to determine the pharmacokinetics (PK) of the anti-flu medication, Tamiflu during pregnancy and to determine to what extent pregnancy may affect the currently recommended dosage of this medication.

Detailed Description

The emergence of the novel H1N1 influenza virus has raised concern among public health officials and the public alike. Although initial reports suggested that the risk of serious disease or death was less than initially feared, continued experience suggests that the disease will have a major impact on the public's health. To address this urgent public health challenge, the centers of the Obstetric-Fetal Pharmacology Research Units Network (OPRU) will recruit a total of 75 pregnant women (25 per trimester with singletons pregnancies) who are receiving oseltamivir for supposed influenza infection. When possible, we will recruit women with twin gestation to determine if fetal number affects the drugs pharmacokinetics. We do not anticipated a significant number of multi-fetal gestations (< 10) but even limited data might prove useful in this population given the tremendous change in renal drug clearance that is normally seen in this group of women. An additional 25 healthy non-pregnant women will be studied to define pregnancy- related changes in the PK of oseltamivir and the carboxylate.

We will study each woman once during therapy, performing steady state pharmacokinetic analyses. This study will be performed after 3 days of oral therapy to optimize the possibility that steady state concentrations have been achieved.

We will:

1. collect biological fluids (plasma and urine) to further characterize the pharmacology of the drug;

2. collect a check swab for DNA to allow study of the impact of single nucleotide polymorphisms on drug handing and disease expression;

3. develop an assay or partner with others to develop an assay for oseltamivir and the primary metabolite, oseltamivir carboxylate;

4. compare the pharmacokinetics of oseltamivir and its metabolite in each trimester of pregnancy to evaluate whether gestational age has an impact on the drug's pharmacokinetics;

5. assess the impact of fetal number on the drug's pharmacokinetics;

6. ask all participants about GI tolerance to the drug and any side effects they may be experiencing, especially related to mood and psychiatric well being; and

7. on all pregnant subjects studied, when possible, we will obtain at delivery maternal and umbilical cord blood to evaluate placental transport especially in those who deliver proximate (within 3 days) to drug treatment.

Conditions

H1N1 Influenza Treatment During Pregnancy

Keywords

H1N1 influenza; Swine flu; Oseltamivir; Tamiflu; Pregnancy

Study Design

• Observational Model Type: COHORT

Study Groups

Tamiflu use during first trimester

This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the first trimester of their pregnancy.

No interventions assigned to this group

Tamiflu use during second trimester

This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the second trimester of their pregnancy.

No interventions assigned to this group

Tamiflu use during third trimester

This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the first trimester of their pregnancy.

No interventions assigned to this group

Tamiflu use in non-pregnant women

This group will consist of twenty-five non-pregnant healthy female volunteers who are being treated with Oseltamivir.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Taking or about to start oral oseltamivir for presumed influenza viral infection or for prophylaxis

2. Able to give informed consent

3. Pregnant female with singleton or multifetal gestation or healthy non-pregnant female (ancillary study)

Exclusion Criteria

1. Unable to take medication orally

2. Renal failure - creatinine > 1.5

3. Hct <28

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Beigi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Steve Caritis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Raman Venkataramanan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

OPRU Tamiflu

Identifier Type: -

Identifier Source: org_study_id