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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 2, 1999 | ||||||||
| Last Updated Date | July 29, 2008 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00000910 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies | ||||||||
| Official Title ICMJE | Medical Chart Abstraction of HIV-Infected Pregnant Women and Their Infants Receiving Care or Consultation at Study Sites | ||||||||
| Brief 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. |
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| 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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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 2000 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria A patient may be eligible for this study if she:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States, Puerto Rico | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00000910 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | ACTG 367, PACTG 367 | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | July 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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