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NCT00869960 · ClinicalTrials.gov registry record · Phase 4
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00869960 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 24 participants.
The verdict
NCT00869960, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not been determined. The primary purpose of this study is to examine whether the pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied. This study will be conducted in healthy women since HIV may change the pharmacokinetics of anti-HIV drugs.
Interventions
- DRUG ritonavir
- DRUG tenofovir
- DRUG emtricitabine
- DRUG atazanavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00869960
The ClinicalTrials.gov registry entry for NCT00869960 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which ritonavir is the first listed.
NCT00869960 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00869960 about?
NCT00869960 is a clinical study titled "Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women". Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not been determined. The primary purpose of this study is to examine whet...
What is the current status of trial NCT00869960?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2009-03. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00869960?
The interventions under investigation include: ritonavir (DRUG), tenofovir (DRUG), emtricitabine (DRUG), atazanavir (DRUG).
Who is sponsoring clinical trial NCT00869960?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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