Pharmacokinetic Study of Anti-HIV Drugs During Pregnancy - Full Text View

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00042289

Purpose

The purpose of this study is to determine what doses of anti-HIV medications are appropriate for pregnant women.

Anti-HIV medication taken during pregnancy may control a woman's viral load and reduce the chance that the baby will become infected with HIV. Pregnant women may require different doses of anti-HIV drugs than women who are not pregnant. This study will use pharmacokinetic (PK) sampling to determine what doses of anti-HIV medications are best for HIV infected pregnant women and their infants.

Condition	Intervention
HIV Infections	Procedure: Pharmacokinetic sampling

MedlinePlus related topics: AIDS AIDS Medicines AIDS and Pregnancy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pharmacokinetic Properties of Antiretroviral Drugs During Pregnancy

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Area under the curve (AUC) [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ratio of cord blood concentration to maternal blood concentration [ Time Frame: throughout study ] [ Designated as safety issue: No ]
ratio of 6-beta-hydroxycortisol to cortisol [ Time Frame: throughout study ] [ Designated as safety issue: No ]
ratio of unbound/total drug concentrations for atazanavir, fosamprenavir, efavirenz, nelfinavir, and tipranavir [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	275
Study Start Date:	March 2003

Arms	Assigned Interventions
1: Experimental Participants will be evaluated in order to determine the most effective dosing regimen in preventing perinatal HIV transmission.	Procedure: Pharmacokinetic sampling sampling to determine most effective dosing regimen

Detailed Description:

Pregnant women experience unique physiological changes that may result in clinically significant alterations in drug PKs. Unfortunately, there have been few clinical trials to study the PK of antiretroviral (ARV) medications in pregnant women. The development of appropriate dosing regimens for the HIV infected pregnant woman is critical to the health of both mother and fetus. Overdosing may lead to maternal adverse events and increased risk of fetal toxicity, while underdosing may lead to inadequate virologic control, increased risk of developing drug resistance mutations, and a higher rate of perinatal HIV transmission. This study will develop and evaluate dosing regimens that are most effective in preventing perinatal HIV transmission and in maintaining the health of both mother and fetus.

Participants will be enrolled in this study starting from their twentieth week of pregnancy and for 12 weeks after delivery. Participants will not receive ARV medications through this study. Medical history, a physical exam, and blood and urine collection will occur during all study visits.

Intensive PK sampling will be performed at study visits during the second and third trimester of pregnancy and between 2 and 3 weeks and 6 and 12 weeks postpartum. The timing of antepartum and postpartum PK samplings will vary by drug. Blood collection from the mother and the detached umbilical cord will occur during delivery. Additional study visits may occur depending on the ARV drug regimen prescribed.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV infected
At least 20 weeks pregnant. If a woman has completed P1026s and becomes pregnant again, she may be eligible to re-enroll in P1026s only if she is receiving a different drug or drug combination than that studied during the first enrollment in P1026s.
Enrolled in PACTG P1025
Must begin one of the study drugs or drug combinations by 34 6/7th week of pregnancy, and must be on the anti-HIV drugs for at least 2 weeks prior to PK sampling

Exclusion Criteria:

Certain medications known to interfere with absorption, metabolism, or clearance of the anti-HIV drug(s) being evaluated
Pregnant with more than one baby
Signs of toxicity that, in the opinion of the site investigator, would be likely to require a change in medication during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042289

Contacts

Contact: Shiara Ortiz-Pujols

301-628-3359

Hide Study Locations

Locations

United States, Alabama
University of Alabama at Birmingham (Pediatric)	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Terry Byars, BSN, MPH 205-558-2328 tbyars@peds.uab.edu
United States, California
UCSD Mother, Child, Adolescent HIV Program	Recruiting
San Diego, California, United States, 92103
Contact: Linda Proctor 619-543-8080 lproctor@ucsd.edu
Long Beach Memorial (Pediatric)	Recruiting
Long Beach, California, United States, 90801
Contact: Susan Marks 562-595-0812 smarks@memorialcare.org
UCSD Mother, Child & Adolescent HIV Program	Recruiting
San Diego, California, United States, 92103
Contact: Linda Proctor 619-543-8080 lproctor@ucsd.edu
UCLA Med Ctr (Pediatrics)	Recruiting
Los Angeles, California, United States, 90090-1752
Contact: Maryanne Dillon 310-825-9660 mdillon@mednet.ucla.edu
UCSF, Moffitt Hosp (Pediatric)	Recruiting
San Francisco, California, United States, 94143-0105
Contact: Debbie Trevithick 415-476-6480 dtrevith@peds.ucsf.edu
Los Angeles County Medical Center/USC	Recruiting
Los Angeles, California, United States, 90033
Contact: Eva A. Operskalski, PhD, MBA 323-226-2226 eva@usc.edu
Harbor-UCLA Medical Center	Active, not recruiting
Torrance, California, United States, 90509
Los Angeles Biomedical Research Institute	Recruiting
Torrance, California, United States, 90502
Contact: Sheryl Sullivan, LVN 310-222-4171 ssullivan@labiomed.org
Principal Investigator: Margaret A. Keller, MD
United States, Colorado
Children's Hospital (U. Colorado, Denver)	Recruiting
Denver, Colorado, United States, 80218-1088
Contact: Carol Salbenblatt, RN, MSN 303-861-6751 salbenblatt.carol@tchden.org
United States, Connecticut
Yale University School of Medicine	Active, not recruiting
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Children's National Med. Ctr. Washington DC NICHD CRS	Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Romuladus E. Azuine, MPH 202-476-3074 razuine@cnmc.org
Principal Investigator: Steven L. Zeichner, MD, PhD
United States, Florida
Univ of Miami (Pediatric)	Recruiting
Miami, Florida, United States, 33136
Contact: Cathie Gamber 305-243-4446 cgamber@med.miami.edu
Jackson Memorial Hosp	Recruiting
Miami, Florida, United States, 33136
Contact: Cathie Gamber 305-243-4446 cgamber@med.miami.edu
USF - Dept. of Pediatrics; Division of Infectious Diseases	Active, not recruiting
St. Petersburg, Florida, United States, 33701
United States, Georgia
Medical College of Georgia	Active, not recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
The University of Chicago Children's Hospital	Recruiting
Chicago, Illinois, United States, 60637
Contact: Pamela Lofton, RN, MSN, CCRC 773-702-3853 plofton@peds.bsd.uchicago.edu
Chicago Children's Memorial Hospital (Pediatric)	Recruiting
Chicago, Illinois, United States, 60614
Contact: Stacy Rogers, BS 773-880-3669 srogers@childrensmemorial.org
University of Illinois	Recruiting
Chicago, Illinois, United States, 60612-7234
Contact: Julia L. Camacho, BSN, RN 312-413-8089 camachoj@uic.edu
Cook County Hospital	Recruiting
Chicago, Illinois, United States, 60612-7324
Contact: Maureen M. Haak, RN, MSN 312-572-4559 mhaak@CORECENTER.org
United States, Louisiana
University Hospital	Recruiting
New Orleans, Louisiana, United States, 70112-2699
Contact: Margaret L. Cowie, BS 504-586-3804 cowie@tulane.edu
United States, Maryland
Shiara Ortiz-Pujols	Recruiting
Silver Spring, Maryland, United States, 20910
University of Maryland (Pediatrics)	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mary MacFadden, RN, BSN 410-706-8933 mmacfadd@peds.umaryland.edu
United States, Massachusetts
Boston Medical Center (Pediatric)	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Kirk Bertelsen 617-414-5813 amregan@bu.edu
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02478
Contact: Arlene Buck, RN, BS 617-732-5111 abuck@partners.org
University of Massachusetts Medical School	Recruiting
Worcester, Massachusetts, United States, 01655-0001
Contact: Donna Christian, MA, CCRC 508-856-1692 donna.christian@umassmed.edu
Baystate Medical Center, Springfield	Active, not recruiting
Springfield, Massachusetts, United States, 01199
United States, Michigan
WSU School of Medicine, Children's Hospital of Michigan	Recruiting
Detroit, Michigan, United States, 48201
Contact: Ulyssa Hancock, RN, BSN 313-45-9204 uhancock@dmc.org
Principal Investigator: Ellen C. Moore, MD
United States, Missouri
St. Louis Children's Hospital	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Laura Pickering, RN, ACRN 314-454-2576 pickering_l@kids.wustl.edu
United States, New Jersey
Univ of Med & Dentistry of NJ/Univ Hosp	Recruiting
Newark, New Jersey, United States, 07103
Contact: Mary Jo Hoyt 973-972-3118 hoyt@umdnj.edu
United States, New York
The Columbia Presbyterian Med Ctr	Recruiting
New York, New York, United States, 10032
Contact: Marie Donahue 212-305-7222 donahum@nyp.org
Jacobi Medical Center	Recruiting
Bronx, New York, United States, 10461
Contact: Wanda Biermick, BSN, RN 718-918-4903 ext 4516 wanda.biermick@nbhn.net
State University of New York at Stony Brook	Active, not recruiting
Stony Brook, New York, United States, 11794-8111
Bronx Lebanon Hospital Center	Recruiting
Bronx, New York, United States, 10457
Contact: Caroline Nubel 718-960-1020 cnubel@bronxleb.org
SUNY Upstate Medical University	Recruiting
Syracuse, New York, United States, 13210
Contact: Maureen J. Famiglietti, BSN, RN 315-464-6331 famiglim@upstate.edu
NYU School of Medicine, Division of Pediatric Infectious Diseases	Recruiting
New York, New York, United States, 10016
Contact: Nagamah Sandra Deygoo 212-263-5680 sandra.deygoo@med.nyu.edu
Principal Investigator: William Borkowsky, MD
United States, North Carolina
Duke University (Pediatric)	Recruiting
Durham, North Carolina, United States, 27705
Contact: John Swetnam, M.Ed 919-416-3447 swetnam@acpub.duke.edu
United States, Pennsylvania
Hahnemann University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19102-1192
Contact: Mary Talucci, CRNP 215-762-3237 mmt27@drexel.edu
Children's Hospital of Philadelphia	Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104-4318
United States, Tennessee
St. Jude Children's Research Hospital, Memphis	Recruiting
Memphis, Tennessee, United States, 38105-2794
Contact: Laura J. Utech, RN, MSN, CCRC 901-495-3490 jill.utech@stjude.org
Vanderbilt University Medical Center	Active, not recruiting
Nashville, Tennessee, United States, 37232-2581
United States, Texas
Texas Children's Hospital/Baylor University	Recruiting
Houston, Texas, United States, 77030
Contact: Chivon Jackson, RN, BSN, ADN 832-824-1339 cdmcmull@texashopita.org
United States, Washington
Children's Hospital and Regional Medical Center	Recruiting
Seattle, Washington, United States, 98105-0371
Contact: Kathleen Mohan, ARNP, MN 206-987-5020 kmohan@u.washington.edu
Northwest Family Center/Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98105-0371
Contact: Kathleen Mohan, ARNP, MN 206-987-5020 kmohan@u.washington.edu
Contact: Deb Goldman, PA-C 206-731-5111 debgold@u.washington.edu
University of Washington Medical Center	Recruiting
Seattle, Washington, United States, 98105-0371
Contact: Kathleen Mohan, ARNP, MN 206-987-5020 kmohan@u.washington.edu
Contact: Deb Goldman, PA-C 206-731-5111 dgold@u.washington.edu
Puerto Rico
San Juan City Hosp	Recruiting
San Juan, Puerto Rico
Contact: Maria del Pilar Thurin 787-765-4186 actg.pedsjch@fstrf.org
Univ of Puerto Rico, U. Children's Hosp AIDS	Recruiting
San Juan, Puerto Rico, 00936-5067
Contact: Sylvia Davila Nieves 787-759-9595 sdavila@rcm.upr.edu

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

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

Investigators

Study Chair:

Mark Mirochnick, MD

Boston Medical Center

More Information

Additional Information:

Click here for more information about drug regimens and pregnancy This link exits the ClinicalTrials.gov site

Click here for more information about drug safety and pregnancy This link exits the ClinicalTrials.gov site

Click here for more information on after birth care for HIV positive women and their babies This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español This link exits the ClinicalTrials.gov site

Publications:

Best BM, Mirochnick M, Capparelli EV, Stek A, Burchett SK, Holland DT, Read JS, Smith E, Hu C, Spector SA, Connor JD; the PACTG P1026s Study Team. Impact of pregnancy on abacavir pharmacokinetics. AIDS. 2006 Feb 28;20(4):553-560.

Stek AM, Mirochnick M, Capparelli E, Best BM, Hu C, Burchett SK, Elgie C, Holland DT, Smith E, Tuomala R, Cotter A, Read JS; for the PACTG 1026s study team. Reduced lopinavir exposure during pregnancy. AIDS. 2006 Oct 3;20(15):1931-1939.

Loutfy MR, Walmsley SL. Treatment of HIV infection in pregnant women: antiretroviral management options. Drugs. 2004;64(5):471-88.

Mirochnick M, Capparelli E. Pharmacokinetics of antiretrovirals in pregnant women. Clin Pharmacokinet. 2004;43(15):1071-87. Review.

Rakhmanina NY, van den Anker JN, Soldin SJ. Safety and pharmacokinetics of antiretroviral therapy during pregnancy. Ther Drug Monit. 2004 Apr;26(2):110-5. Review.

Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. Review.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	PACTG P1026s, PACTG P1025
Study First Received:	July 26, 2002
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00042289 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Pregnancy
Pharmacokinetics
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 13, 2009