Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
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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 |
- 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 ]
- 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 |
| Estimated Primary Completion Date: | December 2014 (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 |
Primary care clinics
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
Show 77 Study Locations| 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: | November 15, 2012 |
| 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 March 14, 2013
