A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies

October 4, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Medical Chart Abstraction of HIV-Infected Pregnant Women and Their Infants Receiving Care or Consultation at Study Sites

The purpose of this study is to collect medical information about HIV-positive pregnant women and their babies who have been (or are being) seen at study sites. This information will be used to help design future research studies for these patients.

The population of HIV-positive pregnant women and their babies who are seen at study sites has not been officially examined. In order to design future studies to research the best care for these patients, this study will examine important characteristics and the general number of women in these trials.

Study Overview

Status

Completed

Conditions

Detailed Description

The population served at affiliated ACTG sites has not been officially described. Anecdotal evidence, however, has surfaced regarding the characteristics of HIV-infected pregnant women and the current standard of care during pregnancy. This chart abstraction study is designed to define, more accurately, the pertinent characteristics and general numbers of women in these trials.

In this medical chart abstraction study, pertinent information is collected on all HIV-infected pregnant women and their infants who receive primary or consultative care at PACTG 367 study sites. Part A profiles all HIV-infected women who received care or consultation at study sites and who had a pregnancy outcome between January 1, 1998 through July 1, 1998. [AS PER AMENDMENT 04/12/02: Part A is closed to enrollment.] Part B profiles HIV-infected pregnant women who receive primary or consultative care and a pregnancy outcome following July 1, 1998.

Study Type

Observational

Enrollment

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp., Div. of Infectious Disease
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers - New Jersey Medical School CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

A patient may be eligible for this study if she:

  • Is an HIV-positive woman.
  • Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available.
  • Had a baby on or after January 1, 1998.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Study Chair: Renee Samelson

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (ACTUAL)

June 1, 2004

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2013

Last Update Submitted That Met QC Criteria

October 4, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 367
  • 11330 (REGISTRY: DAIDS-ES)
  • PACTG 367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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