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Prenatal and Postnatal Studies Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Prenatal and Postnatal Studies conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Prenatal and Postnatal Studies Clinical research trials and Prenatal and Postnatal Studies health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Prenatal and Postnatal Studies. Prenatal and Postnatal Studies Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Prenatal and Postnatal Studies clinical trial. Test subjects typically receive the most expert healthcare available for their Prenatal and Postnatal Studies condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

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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

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