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NCT00042289 · ClinicalTrials.gov registry record
Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 1,578
- Enrollment target
NCT00042289: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00042289 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,578 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00042289 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 1,578 participants
- Enrollment target
Study Summary
IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study also evaluated the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs were evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
Primary Outcome
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
Interventions
- DRUG atazanavir/cobicistat
- DRUG darunavir/ritonavir dosage #1
- DRUG darunavir/ritonavir dosage #2
- DRUG darunavir/ritonavir dosage #3
- DRUG elvitegravir/cobicistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,578 participants |
| Start Date | 2003-06-09 |
| Est. Completion | 2020-09-30 |
What the finished NCT00042289 record still lists
NCT00042289 is an observational study that tracks outcomes without assigning an intervention. Its 1,578 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 5 interventions - of which atazanavir/cobicistat is the first listed.
NCT00042289 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00042289 about?
NCT00042289 is a clinical study titled "Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy". IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study also evaluated the PKs...
What is the current status of trial NCT00042289?
This trial is currently completed. The enrollment target is 1,578 participants. The study started on 2003-06-09. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT00042289?
The interventions under investigation include: atazanavir/cobicistat (DRUG), darunavir/ritonavir dosage #1 (DRUG), darunavir/ritonavir dosage #2 (DRUG), darunavir/ritonavir dosage #3 (DRUG), elvitegravir/cobicistat (DRUG).
Who is sponsoring clinical trial NCT00042289?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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