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NCT00342082 · ClinicalTrials.gov registry record
Effects of Anti-HIV Therapy on Red Blood Cells of HIV-infected Mothers and Their Infants
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
NCT00342082 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS).
The verdict
NCT00342082 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
Study Summary
This collaborative investigation between NIEHS, Duke University, and the University of North Carolina (UNC) will study red blood cells of babies born to HIV-infected women receiving anti-retroviral treatment. Studies have shown that newborn mice whose mothers were given anti-HIV medications during pregnancy had abnormal red blood cells circulating in their blood stream, indicating genetic damage to the cells caused by the anti-HIV medications. It is not known if similar red blood cell abnormalities develop in human infants whose mothers received anti-HIV medication during their pregnancy. This study will examine red blood cells from infants exposed to anti-HIV medications and from non-exposed infants to look for differences between them involving this specific genetic damage. Healthy pregnant women and HIV-infected pregnant women who received antiretroviral treatment during their last trimester of pregnancy and during labor may be eligible for this study. Babies of HIV-infected women are also included in the study. Candidates will be recruited from medical centers at Duke University and the UNC. HIV-infected mothers must plan to have their baby followed by either the UNC or the Duke Pediatric Infectious Disease clinic. All women in the study will have 1 milliliter (less than 1/2 teaspoon) of blood collected for this study during delivery at the same time that other blood samples are obtained for their medical care. In addition, 5 ml (1 teaspoon) of umbilical cord blood will also be collected for this study at the time of delivery after the cord is no longer attached to the baby. This concludes participation of non-HIV infected women. Babies born to HIV-infected mothers will have 1 ml of blood drawn between 0 to 3 days of life, between 4 to 6 weeks of life, and between 4 to 6 months of life. These bloodsamples will be collected at the same time as other routine scheduled blood draws.
Trial Details
| Field | Value |
|---|---|
| Start Date | 2004-06-25 |
| Est. Completion | 2007-12-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00342082
The ClinicalTrials.gov registry entry for NCT00342082 describes a study currently listed as completed, categorized as an unspecified phase. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00342082 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00342082 about?
NCT00342082 is a clinical study titled "Effects of Anti-HIV Therapy on Red Blood Cells of HIV-infected Mothers and Their Infants". This collaborative investigation between NIEHS, Duke University, and the University of North Carolina (UNC) will study red blood cells of babies born to HIV-infected women receiving anti-retroviral treatment. Studies have shown that newborn mice whose mothers were given anti-HIV medications during p...
What is the current status of trial NCT00342082?
This trial is currently completed. The study started on 2004-06-25. Estimated completion is 2007-12-28.
Who is sponsoring clinical trial NCT00342082?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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