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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 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.

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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.

Interventions

  • DRUG atazanavir/cobicistat
  • DRUG darunavir/ritonavir dosage #1
  • DRUG darunavir/ritonavir dosage #2
  • DRUG darunavir/ritonavir dosage #3
  • DRUG elvitegravir/cobicistat

Trial Details

FieldValue
Enrollment Target 1,578 participants
Start Date 2003-06-09
Est. Completion 2020-09-30

What the Registry Record Tells You About NCT00042289

The ClinicalTrials.gov registry entry for NCT00042289 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,578 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which atazanavir/cobicistat is the first listed.

NCT00042289 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.