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NCT00006320 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women
A Phase 1 study of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00006320: Completed Phase 1 study of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00006320 is a Phase 1 study of HIV Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 243-participant average among 73 other HIV Infection trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006320, a Phase 1 study of HIV Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine if blood levels of anti-HIV drugs in pregnant women change at different stages of pregnancy and if these changes require dosage adjustments in order to maintain adequate drug levels during pregnancy. Anti-HIV medications are recommended for HIV-infected women during pregnancy not only to treat their infection, but also to reduce the chance of passing the virus to the baby during pregnancy. Changes in the body that occur during pregnancy may affect how the body uses and eliminates these drugs, reducing their levels during pregnancy. Pregnant women 18 years of age or older who are infected with HIV may be eligible for this study. Candidates will have a medical history and physical examination, pregnancy test and blood tests. Participants will come to the NIH Clinical Center once every 6 to 12 weeks until around their 34th week (8 months) of pregnancy and then again at least 1 month after the birth of the baby to have blood drawn. A catheter (thin plastic tube) will be placed in a vein to avoid multiple needle sticks for blood sampling during the day. The first sample will be collected before the patient takes the morning doses of anti-HIV medicines and additional samples will be drawn at 1, 2, 4, 8 and 12 hours after taking the medication. A urine sample will also be collected at each visit.
Conditions Studied
Interventions
- PROCEDURE determine blood levels of anti-HIV drugs
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2000-09 |
| Est. Completion | 2004-07 |
| Phase | Phase 1 |
What the finished NCT00006320 record still lists
NCT00006320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 243-participant average among 73 other HIV Infection trials with a reported enrollment target (92% lower).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which determine blood levels of anti-HIV drugs is the first listed.
NCT00006320 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00006320 about?
NCT00006320 is a clinical study titled "Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women". This study will determine if blood levels of anti-HIV drugs in pregnant women change at different stages of pregnancy and if these changes require dosage adjustments in order to maintain adequate drug levels during pregnancy. Anti-HIV medications are recommended for HIV-infected women during pregnan...
What is the current status of trial NCT00006320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2000-09. Estimated completion is 2004-07.
What conditions does trial NCT00006320 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00006320?
The interventions under investigation include: determine blood levels of anti-HIV drugs (PROCEDURE).
Who is sponsoring clinical trial NCT00006320?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00006320 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00006320's enrollment target sits among peer trials
20 60th of 73 higher than 11 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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