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NCT01386970 · ClinicalTrials.gov registry record · Phase 4

Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics

A Phase 4 study of HIV, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 4
Development phase
43
Enrollment target
1
Study location

NCT01386970 is a Phase 4 study of HIV that has completed, run by University of Colorado, Denver. The registered enrollment target is 43 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01386970, a Phase 4 study of HIV, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 4
Development phase
43 participants
Enrollment target
1
Study location

Study Summary

This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection. Additionally, markers of side effects were correlated with blood levels of the drugs. The hypothesis was that women and those with HIV would have higher drug levels, as well as markers of side effects.

Conditions Studied

Interventions

  • DRUG zidovudine 300mg and lamivudine 150mg as Combivir

Study Locations (1)

Colorado

  • University of Colorado Denver and Health Sciences Center - Aurora

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2005-05
Est. Completion 2010-07
Phase Phase 4

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT01386970

The ClinicalTrials.gov registry entry for NCT01386970 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which zidovudine 300mg and lamivudine 150mg as Combivir is the first listed.

NCT01386970 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT01386970 about?

NCT01386970 is a clinical study titled "Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics". This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection. Additionally, markers of side effects were correlated with blood levels of the drugs. The hypothesis was that women and those with HIV would h...

What is the current status of trial NCT01386970?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2005-05. Estimated completion is 2010-07.

What conditions does trial NCT01386970 study?

This clinical trial studies the following conditions: HIV.

What interventions are being tested in trial NCT01386970?

The interventions under investigation include: zidovudine 300mg and lamivudine 150mg as Combivir (DRUG).

Who is sponsoring clinical trial NCT01386970?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01386970 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.