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

This study has been completed.
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: October 8, 2014
Last verified: October 2014

December 13, 2001
October 8, 2014
October 2002
June 2013   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00028145 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
Perinatal Core Protocol

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and amniotic fluid

Probability Sample

Primary care clinics

  • HIV Infections
  • Pregnancy Complications, Infectious
Behavioral: Adherence assessment
Adherence will be assessed using questionnaires at all study visits.
1
Pregnant, HIV-infected women
Intervention: Behavioral: Adherence assessment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3090
June 2013
June 2013   (final data collection date for primary outcome measure)

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)
Female
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00028145
PACTG P1025, U01AI068632
Yes
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP