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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
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 |
| 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 |
| Estimated Enrollment: | 275 |
| Study Start Date: | March 2003 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| 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
PK sampling to determine most effective dosing regimen
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Emily F. Demske | 301-628-3322 |
Hide Study 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 | |
| Study Chair: | Mark Mirochnick, MD | Boston Medical Center |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | IMPAACT P1026s, IMPAACT P1025 |
| Study First Received: | July 26, 2002 |
| Last Updated: | June 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00042289 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pregnancy Pharmacokinetics Treatment Experienced |
|
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 |
