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CompletedNCT00000910Updated Oct 7, 2013

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

An observational study in HIV Infections and Pregnancy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2013-10-07.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
2,000
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • HIV Infections
  • Pregnancy

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Keywords

  • Pregnancy
  • Anti-HIV Agents
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In context

HIV Infections

4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 2,000 is above the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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.
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Study design

Time perspective
Prospective
Enrollment
2,000 participants
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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000910
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Aug 31, 2001
Completion
Jun 2004
Last update
Oct 7, 2013

Study contacts

Ruth Tuomala
study chair
Renee Samelson
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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