Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00028145
First received: December 13, 2001
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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 Intervention
HIV Infections
Pregnancy Complications, Infectious
Behavioral: Adherence assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perinatal Core Protocol

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Maternal and infant response to prescribed interventions [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Immune and viral parameters of participants taking prescribed interventions [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrences of genotypic and phenotypic resistance in HIV-infected mothers [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Clinical, immunological, and virological responses in HIV-infected women [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Mother-to-child transmission rates of resistance mutations [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood and amniotic fluid


Estimated Enrollment: 3200
Study Start Date: October 2002
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Pregnant, HIV-infected women
Behavioral: Adherence assessment
Adherence will be assessed using questionnaires at all study visits.

Detailed Description:

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 theInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) 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 IMPAACT 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.

Participants 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 6 months postpartum and their infants for the first 6 months of life. There will be 8 study visits for enrolled participants and 6 study visits for infants. Data concerning ART use, adherence to medications, and review of symptoms relevant to side effects and toxicities are collected through administration of questionnaires at all maternal visits. 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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinics

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 an IMPAACT 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 an IMPAACT 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028145

  Hide Study Locations
Locations
United States, Alabama
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, United States, 35233
University of South Alabama
Mobile, Alabama, United States, 36688
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85006
United States, California
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Miller Children's Hospital Long Beach (5093)
Long Beach, California, United States, 90806
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, California, United States, 90095
Usc La Nichd Crs (5048)
Los Angeles, California, United States, 90033
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Los Angeles County Medical Center/USC
Los Angeles, California, United States, 90033
Univ of California, San Diego (4601)
San Diego, California, United States, 92103
Univ. of California San Francisco NICHD CRS (5091)
San Francisco, California, United States, 94117
Harbor-UCLA Med Ctr (5045)
Torrance, California, United States, 90509
United States, Colorado
University of Colorado Denver NICHD CRS (5052)
Denver, Colorado, United States, 80218-1088
United States, Connecticut
Connecticut Childrens Medical Center (Pediatric)
Farmington, Connecticut, United States, 06030-3805
University of Connecticut, Farmington
Farmington, Connecticut, United States, 06030-3805
Yale Univ School of Med
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Washington Hospital Center NICHD CRS (5023)
Washington, District of Columbia, United States, 200102931
Howard Univ Hosp (5044)
Washington, District of Columbia, United States, 20060
Children's National Medical Center Washington DC NICHD CRS (5015)
Washington, District of Columbia, United States, 20010-2970
United States, Florida
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33311
South Florida CDC Ft Lauderdale NICHD CRS (5055)
Ft Lauderdal, Florida, United States, 33316
University of Florida Jacksonville (5051)
Jacksonville, Florida, United States, 32209
Jackson Memorial Hosp
Miami, Florida, United States, 33136
University of Miami Pediatric/Perinatal HIV/AIDS (4201)
Miami, Florida, United States, 33136
University of South Florida at Tampa (5018)
St Petersburg, Florida, United States, 33701
United States, Georgia
Med College of Georgia
Augusta, Georgia, United States, 30912
The Medical Center
Columbus, Georgia, United States, 31901
United States, Illinois
Cook County Hospital
Chicago, Illinois, United States, 60612
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States, 60608
Univ of Chicago Children's Hosp (4001)
Chicago, Illinois, United States, 60637-1470
Chicago Childrens Memorial Hosp (Pediatric)
Chicago, Illinois, United States, 60614
Univ of Illinois
Chicago, Illinois, United States, 60612-7234
Womens & Childrens HIV Program
Chicago, Illinois, United States, 60608-1797
Rush University Cook County Hospital NICHD CRS (5083)
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane University Charity Hosp of New Orleans (7201)
New Orleans, Louisiana, United States, 70112
Tulane University New Orleans (5095)
New Orleans, Louisiana, United States, 70112-2699
Tulane-Lakeside Hospital
New Orleans, Louisiana, United States, 70112-2699
United States, Maryland
University of Maryland Baltimore NICHD CRS (5094)
Baltimore, Maryland, United States, 21201
Johns Hopkins University NICHD CRS (5092)
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Med Ctr (Pediatric) (5011)
Boston, Massachusetts, United States, 02118
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, United States, 02115
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02478
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 01655
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, United States, 01605
United States, Michigan
Wayne State University Detroit Children's Hosp of Michigan (5041)
Detroit, Michigan, United States, 48201
Hutzel Hospital (5089)
Detroit, Michigan, United States, 48201-1427
United States, Missouri
St. Louis Children's Hosp
St. Louis, Missouri, United States, 63108-2138
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
Newark, New Jersey, United States, 07103-2714
Univ of Med & Dentistry of New Jersey/Univ Hosp
Newark, New Jersey, United States, 07103
New Jersey Medical School (2802)
Newark, New Jersey, United States, 07103
United States, New York
Montefiore Medical / AECOM
Bronx, New York, United States, 19461
Lincoln Medical & Mental Health Center
Bronx, New York, United States, 10451
Jacobi Med. Ctr. Bronx NICHD CRS (5013)
Bronx, New York, United States, 10461
Bronx-Lebanon Hospital IMPAACT (6901)
Bronx, New York, United States, 10457
Children's Hospital at Downstate
Brooklyn, New York, United States, 11203-2098
Metropolitan Hosp Ctr (5003)
New York, New York, United States, 10029
NYU/Bellevue Hospital
New York, New York, United States, 10016
Columbia IMPAACT CRS (4101)
New York, New York, United States, 10032
New York University NY (5012)
New York, New York, United States, 10016
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
State Univ of New York at Stony Brook (5040)
Stony Brook, New York, United States, 11776
SUNY Upstate Medical Univ
Syracuse, New York, United States, 13210
United States, North Carolina
Duke Univ (Pediatric) (DUMC) (4701)
Durham, North Carolina, United States, 27705
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
The Children's Hospital of Philadelphia (6701)
Philadelphia, Pennsylvania, United States, 19134
Hahnemann University Hospital (6706)
Philadelphia, Pennsylvania, United States, 19102-1192
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
The Regional Med Ctr, Memphis (6502)
Memphis, Tennessee, United States, 38105-2794
St. Jude Childrens Research Hosp, Memphis (6501)
Memphis, Tennessee, United States, 38105
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Children's Hosp / Baylor Univ (3801)
Houston, Texas, United States, 77030
United States, Washington
Univ of Washington Children's Hospital Seattle (5017)
Seattle, Washington, United States, 98105-0371
Harborview Medical Center NICHD CRS (5027)
Seattle, Washington, United States, 98105
University of Washington NICHD CRS (5029)
Seattle, Washington, United States, 98105
Puerto Rico
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, Puerto Rico, 00936-7344
University of Puerto Rico Pediatric HIV/AIDS (6601)
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Investigators
Study Chair: Ruth Tuomala, MD Director of Obstetrics and Gynecology, Brigham and Women's Hospital
Study Chair: Gwen Scott, MD Pediatric Infectious Diseases, University of Miami School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00028145     History of Changes
Other Study ID Numbers: PACTG P1025, U01AI068632
Study First Received: December 13, 2001
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
Women's Health
Disease Transmission, Vertical
Preventive Medicine
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
Infection
Pregnancy Complications
Pregnancy Complications, Infectious
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014