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NCT00000910 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000910
Other study ID # ACTG 367
Secondary ID PACTG 36711330
Status Completed
Phase N/A
First received November 2, 1999
Last updated October 4, 2013
Est. completion date June 2004

Study information
Verified date October 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Brigham and Women's Hosp., Div. of Infectious Disease Boston Massachusetts
United States Rutgers - New Jersey Medical School CRS Newark New Jersey

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

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