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Home > "P" Clinical Trials Conditions > Prenatal and Postnatal Studies Prenatal and Postnatal Studies
Prenatal and Postnatal Studies
For Condition: Pregnancy Complications, Infectious,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children. The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.
Details: The current low rate of vertical transmission of HIV in the U.S. limits the number and types of questions concerning transmission risk and pathogenesis that can be addressed by a single clinical trial. Specific U.S. Public Health Service guidelines recommend ART during pregnancy to maximize health of women. However, data regarding the effectiveness and safety of and adherence to ART during pregnancy are limited. It is both appropriate and necessary for the PACTG to recruit pregnant women into a non-interventional, analytic, epidemiologic study to methodically collect clinical and laboratory data from them and their infants. This way, the PACTG can achieve the aims of evaluating management of HIV-infected women during pregnancy and determining the safety and effectiveness of ART and other interventions intended to prevent vertical transmission and/or improve maternal health. In addition, longitudinally collected core protocol data and repository specimens will enable future substudies. Patients receive no protocol specific treatment or other intervention as part of this study. The study involves the follow-up of HIV-infected women enrolled during pregnancy or at the time of delivery to 24 months postpartum and their infants during the first 6 to 12 months of life. Data concerning ART use, adherence to medications, and review of symptoms relevant to side effects and toxicities are collected through administration of questionnaires. Phlebotomy is conducted in order to obtain specimens for a repository and for required laboratory tests. During labor and delivery, maternal blood is obtained for lymphocyte subset and viral load assays and for repository storage. Collection of amniotic fluid at the time of cesarean section is encouraged. These collections are submitted to a central repository. Data for the core protocol are abstracted from the infant's medical record at the time of birth and at each postnatal visit.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 13 years of age or older or age of local requirements, whichever is higher. If under 18 years, patients must have consent of a parent or guardian. - Are HIV-infected. - Are at least 14 weeks pregnant or have delivered a liveborn or stillborn infant within 7 days. - Can provide proof of their HIV infection. - Are receiving care at a PACTG or other participating site. Exclusion Criteria Patients will not be eligible for this study if they: - Intend to end the pregnancy. - Are unable to come for a study visit within 7 days of delivery. - Are enrolled in study PACTG 367.
Total Enrollment: 4800
Location and Contact Information:
Overall Study Official:
GwenScott, Study Chair, University of Miami School of Medicine
Children's National Med Ctr *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Veronica Amos 202-884-2837
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Mary Caffery 619-543-8080
Texas Children's Hosp / Baylor Univ *Recruiting*
Houston, Texas, 77030
United States
Recruiting Kathryn Owl 832-824-2583
St. Christophers Hosp. for Children, Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19134
United States
Recruiting Janet Chen 215-427-5284
Mt Sinai Hosp Med Ctr / Dept of Pediatrics *Recruiting*
Chicago, Illinois, 60608
United States
Recruiting D'andrea Freemon 773-257-5717
Children's Hosp of Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Kirk Bertelsen 617-355-8198
Tulane Univ Hosp, New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Margaret Cowie 504-586-3804
Univ of Maryland (Pediatric) *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Mary MacFadden 410-706-8933
North Broward Hosp District *Recruiting*
Ft. Lauderdale, Florida, 33311
United States
Recruiting Deanna Cruz 954-728-1125
The Medical Center *Recruiting*
Columbus, Georgia, 31901
United States
Recruiting Dawn Barnes 706-571-1449
Los Angeles County Medical Center/USC *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Eva Operskalski 323-226-2342
Univ of Chicago Children's Hosp *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Pamela Lofton 773-702-4853
Hutzel Hosp *Recruiting*
Detroit, Michigan, 48201-1427
United States
Recruiting Dianne Allen 313-993-2681
St. Louis Children's Hosp *Recruiting*
St. Louis, Missouri, 63108-2138
United States
Recruiting Laura Stiffler 314-454-2576
Howard Univ Hosp *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Patricia Yu 202-865-4578
State Univ of New York at Stony Brook *Recruiting*
Stony Brook, New York, 11776
United States
Recruiting Michell Davi 631-444-1313
Bronx Lebanon Hosp Ctr *Recruiting*
Bronx, New York, 10457
United States
Recruiting Caroline Nubel 718-960-1010
Univ of Med & Dentistry of NJ/Univ Hosp *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Mary Hoyt 973-972-3118
The Columbia Presbyterian Med Ctr *Recruiting*
New York City, New York, 10032
United States
Recruiting Marie Donahue 212-305-7222
Univ of Illinois *Recruiting*
Chicago, Illinois, 60612-7234
United States
Recruiting Julia Camacho 312-413-8089
Hahnemann Univ Hosp *Recruiting*
Philadelphia, Pennsylvania, 19102-1192
United States
Recruiting Mary Talucci 215-762-3237
Univ Hosp *Recruiting*
New Orleans, Louisiana, 70112-2699
United States
Recruiting Margaret Cowie 504-586-3804
Univ of Puerto Rico, U. Childrens Hospital AIDS *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Sylvia Davila Nieves 787-759-9595
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Nagamah Deygoo 212-263-6426
Jackson Memorial Hosp *Recruiting*
Miami, Florida, 33136
United States
Recruiting Patricia Bryan 305-243-4447
SUNY Upstate Medical Univ *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Maureen Famiglietti 312-464-6331
Children's Hosp of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Charnell Cromer 313-745-7857
Univ of Florida Health Science Ctr / Pediatrics *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Michelle Eagle 904-244-5331
UCLA Med Ctr / Pediatric *Recruiting*
Los Angeles, California, 900951752
United States
Recruiting Maryanne Dillon 310-825-9660
Duke Univ (Pediatric) *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting John Swetnam 919-416-3447
Med College of Georgia *Recruiting*
Augusta, Georgia, 30912
United States
Recruiting Susan Cobb 706-721-2437
University of Connecticut, Farmington *Recruiting*
Farmington, Connecticut, 06030-3805
United States
Recruiting Gail Karas 860-679-2320
Children's Hospital and Regional Medical Center *Recruiting*
Seattle, Massachusetts, 98105-0371
United States
Recruiting Kathleen Mohan 206-987-5020
Cook County Hosp *No longer recruiting*
Chicago, Illinois, 60612
United States
No longer recruiting
Connecticut Childrens Medical Center (Pediatric) *Recruiting*
Farmington, Connecticut, 06030-3805
United States
Recruiting Gail Karas 860-679-2320
Brigham and Women's Hosp *Recruiting*
Boston, Massachusetts, 02478
United States
Recruiting Arlene Buck 617-732-5111
Metropolitan Hosp Ctr *No longer recruiting*
New York City, New York, 10029
United States
No longer recruiting
Univ of Miami (Pediatric) *Recruiting*
Miami, Florida, 33136
United States
Recruiting Patricia Bryan 305-243-4447
Chicago Childrens Memorial Hosp (Pediatric) *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Debbie Fonken-Cloutier 773-880-3669
Washington Hosp Ctr *Recruiting*
Washington D.C., District of Columbia, 200102931
United States
Recruiting Marla Shauer 202-877-5811
Long Beach Memorial (Pediatric) *Recruiting*
Long Beach, California, 90801
United States
Recruiting Susan Marks 562-595-0812
The Regional Med Ctr, Memphis *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Jill Utech 901-495-3490
St. Jude Childrens Research Hosp, Memphis *Recruiting*
Memphis, Tennessee, 38105
United States
Recruiting Jill Tech 901-495-3490
Univ of Massachusetts Med School *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Donna Christian 508-856-1692
Vanderbilt Univ Med Ctr *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Peggy Bender 615-322-2250
Montefiore Medical / AECOM *No longer recruiting*
Bronx, New York, 19461
United States
No longer recruiting
Childrens Hosp (U. Colorado, Denver) *Recruiting*
Denver, Colorado, 80218-1088
United States
Recruiting Carol Salbenblatt 303-861-6751
Univ of Alabama at Birmingham - Pediatric *No longer recruiting*
Birmingham, Alabama, 35233
United States
No longer recruiting
Harbor-UCLA Med Ctr *Recruiting*
Torrance, California, 90509
United States
Recruiting Judy Hayes 310-222-4173
San Juan City Hosp *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Maria Pilar Thurin (787)765-4186
Tulane Univ., Charity Hosp of New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Margaret Cowie 504-586-3804
Baystate Med Ctr of Springfield *Recruiting*
Springfield, Massachusetts, 01199
United States
Recruiting MariPat Toye 413-794-5399
Boston Med Ctr (Pediatric) *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Anne Regan 617-414-5813
Univ of Rochester Med Ctr *No longer recruiting*
Rochester, New York, 14642
United States
No longer recruiting
Yale Univ School of Med *Recruiting*
New Haven, Connecticut, 06504
United States
Recruiting Donna Schroeder 203-688-6093
Univ of Medicine & Dentistry of New Jersey / Univ Hosp *Recruiting*
Newark, New Jersey, 07103-2714
United States
Recruiting Mary Hoyt 973-972-3118
Additional Information:
Study ID Numbers: PACTG P1025;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028145
Other Hiv Infections Studies:
1. Prenatal and Postnatal Studies
Related Studies:
Other HIV Infections Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Prenatal and Postnatal Studies
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