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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00028145 |
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 |
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HIV Infections Pregnancy Complications, Infectious |
Behavioral: Adherence assessment |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Perinatal Core Protocol |
Blood and amniotic fluid
Estimated Enrollment: | 3200 |
Study Start Date: | October 2002 |
Groups/Cohorts | Assigned Interventions |
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1
Pregnant, HIV-infected women
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Behavioral: Adherence assessment
Adherence will be assessed using questionnaires at all study visits.
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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 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.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Primary care clinics
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | PACTG P1025 |
Study First Received: | December 13, 2001 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00028145 History of Changes |
Health Authority: | United States: Federal Government |
Women's Health Disease Transmission, Vertical Preventive Medicine Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Pregnancy Complications HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Pregnancy Complications, Infectious Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Pregnancy Complications Immune System Diseases Acquired Immunodeficiency Syndrome Pregnancy Complications, Infectious |
Infection Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |