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.

Condition
HIV Infections Pregnancy Complications, Infectious

Further Study Details: 

Expected Total Enrollment:  4800

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 antiretroviral therapy (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 for 12 months postpartum and their infants for 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 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.

Ages Eligible for Study:  14 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• HIV infected
• At least 14 weeks pregnant OR have delivered a liveborn or stillborn infant and are within 14 days of the delivery
• Currently receiving care at a PACTG or other participating site
• Have a parent or guardian willing to provide signed informed consent, if applicable
• Mentally capable of giving informed consent to have the infant and self followed at a PACTG site

Exclusion Criteria:

• Intend to end the pregnancy
• Unable to come for a study visit within 14 days after delivery (if known to be HIV infected prior to delivery) OR within 28 days after delivery (if found to be HIV infected at the time of labor and delivery or within 14 days after delivery)
• Currently enrolled in study PACTG 367

Alabama
      Univ of Alabama at Birmingham - Pediatric, Birmingham,  Alabama,  35233,  United States; No longer recruiting
      University of South Alabama, Mobile,  Alabama,  36688,  United States; Recruiting
Arizona
      Phoenix Childrens Hospital, Phoenix,  Arizona,  85006,  United States; Recruiting
California
      UCLA Med Ctr / Pediatric, Los Angeles,  California,  900951752,  United States; Recruiting
      Univ of California, San Diego, San Diego,  California,  92103,  United States; Recruiting
      Long Beach Memorial (Pediatric), Long Beach,  California,  90801,  United States; Recruiting
      Harbor-UCLA Med Ctr, Torrance,  California,  90509,  United States; Recruiting
      Los Angeles County Medical Center/USC, Los Angeles,  California,  90033,  United States; Recruiting
Colorado
      Childrens Hosp (U. Colorado, Denver), Denver,  Colorado,  80218-1088,  United States; Recruiting
Connecticut
      Yale Univ School of Med, New Haven,  Connecticut,  06504,  United States; Recruiting
      Connecticut Childrens Medical Center (Pediatric), Farmington,  Connecticut,  06030-3805,  United States; Recruiting
      University of Connecticut, Farmington, Farmington,  Connecticut,  06030-3805,  United States; Recruiting
District of Columbia
      Washington Hosp Ctr, Washington,  District of Columbia,  200102931,  United States; Recruiting
      Howard Univ Hosp, Washington,  District of Columbia,  20060,  United States; Recruiting
      Children's National Med Ctr, Washington,  District of Columbia,  20010-2970,  United States; Recruiting
Florida
      Univ of Florida Health Science Ctr / Pediatrics, Jacksonville,  Florida,  32209,  United States; Recruiting
      North Broward Hosp District, Fort Lauderdale,  Florida,  33311,  United States; Recruiting
      Univ of Miami (Pediatric), Miami,  Florida,  33136,  United States; Recruiting
      Jackson Memorial Hosp, Miami,  Florida,  33136,  United States; Recruiting
Georgia
      Med College of Georgia, Augusta,  Georgia,  30912,  United States; Recruiting
      The Medical Center, Columbus,  Georgia,  31901,  United States; Recruiting
Illinois
      Cook County Hospital, Chicago,  Illinois,  60612,  United States; Recruiting
      Mt Sinai Hosp Med Ctr / Dept of Pediatrics, Chicago,  Illinois,  60608,  United States; Recruiting
      Univ of Chicago Children's Hosp, Chicago,  Illinois,  60637-1470,  United States; Recruiting
      Chicago Childrens Memorial Hosp (Pediatric), Chicago,  Illinois,  60614,  United States; Recruiting
      Univ of Illinois, Chicago,  Illinois,  60612-7234,  United States; Recruiting
      Womens & Childrens HIV Program, Chicago,  Illinois,  60608-1797,  United States; Recruiting
Louisiana
      Tulane University Charity Hosp of New Orleans, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Univ Hosp, New Orleans,  Louisiana,  70112-2699,  United States; Recruiting
Maryland
      Univ of Maryland (Pediatric), Baltimore,  Maryland,  21201,  United States; Recruiting
Massachusetts
      Baystate Med Ctr of Springfield, Springfield,  Massachusetts,  01199,  United States; Recruiting
      Boston Med Ctr (Pediatric), Boston,  Massachusetts,  02118,  United States; Recruiting
      Univ of Massachusetts Med School, Worcester,  Massachusetts,  01655,  United States; Recruiting
      Children's Hosp of Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
      Brigham and Women's Hosp, Boston,  Massachusetts,  02478,  United States; Recruiting
Michigan
      Children's Hosp of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
      Hutzel Hosp, Detroit,  Michigan,  48201-1427,  United States; Recruiting
Missouri
      St. Louis Children's Hosp, St. Louis,  Missouri,  63108-2138,  United States; Recruiting
New Jersey
      Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark,  New Jersey,  07103-2714,  United States; Recruiting
      Univ of Med & Dentistry of New Jersey/Univ Hosp, Newark,  New Jersey,  07103,  United States; Recruiting
New York
      NYU/Bellevue Hospital, New York,  New York,  10016,  United States; Recruiting
      Metropolitan Hosp Ctr, New York,  New York,  10029,  United States; No longer recruiting
      Montefiore Medical / AECOM, Bronx,  New York,  19461,  United States; No longer recruiting
      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10457,  United States; Recruiting
      Univ of Rochester Med Ctr, Rochester,  New York,  14642,  United States; No longer recruiting
      State Univ of New York at Stony Brook, Stony Brook,  New York,  11776,  United States; Recruiting
      SUNY Upstate Medical Univ, Syracuse,  New York,  13210,  United States; Recruiting
      The Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States; Recruiting
North Carolina
      Duke Univ (Pediatric), Durham,  North Carolina,  27705,  United States; Recruiting
Oregon
      Oregon Health and Science University, Portland,  Oregon,  97239,  United States; Recruiting
Pennsylvania
      St. Christophers Hosp. for Children, Philadelphia, Philadelphia,  Pennsylvania,  19134,  United States; Recruiting
      Hahnemann Univ Hosp, Philadelphia,  Pennsylvania,  19102-1192,  United States; Recruiting
Tennessee
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  37232,  United States; Recruiting
      St. Jude Childrens Research Hosp, Memphis, Memphis,  Tennessee,  38105,  United States; Recruiting
      The Regional Med Ctr, Memphis, Memphis,  Tennessee,  38105-2794,  United States; Recruiting
Texas
      Texas Children's Hosp / Baylor Univ, Houston,  Texas,  77030,  United States; Recruiting
Washington
      Children's Hospital and Regional Medical Center, Seattle,  Washington,  98105-0371,  United States; Recruiting
Puerto Rico
      San Juan City Hosp, San Juan,  00936-7344,  Puerto Rico; Recruiting
      Univ of Puerto Rico, U. Childrens Hospital AIDS, San Juan,  00936-5067,  Puerto Rico; Recruiting

Study chairs or principal investigators

Ruth Tuomala, MD,  Study Chair,  Director of Obstetrics and Gynecology, Brigham and Women's Hospital   
Gwen Scott, MD,  Study Chair,  Pediatric Infectious Diseases, University of Miami School of Medicine   

Study ID Numbers:  PACTG P1025
Record last reviewed:  February 2005
Last Updated:  April 7, 2005
Record first received:  December 13, 2001
ClinicalTrials.gov Identifier:  NCT00028145
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08