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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Completion Date

2004-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Pregnancy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pregnancy Anti-HIV Agents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruth Tuomala

Role: STUDY_CHAIR

Renee Samelson

Role: STUDY_CHAIR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hosp., Div. of Infectious Disease

Boston, Massachusetts, United States

Site Status

Rutgers - New Jersey Medical School CRS

Newark, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Puerto Rico United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PACTG 367

Identifier Type: -

Identifier Source: secondary_id

11330

Identifier Type: REGISTRY