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

  Show 77 Study Locations
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
Pregnancy Complications
Pregnancy Complications, Infectious
Communicable Diseases
Infection
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