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NCT00014014 · ClinicalTrials.gov registry record · Phase 1

Zidovudine and Lamivudine Given Once Versus Twice Daily

A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
20
Study locations

NCT00014014 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00014014, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to see if the full daily dose of Combivir (zidovudine \[ZDV\]/lamivudine \[3TC\]) taken once a day is as effective as the usual recommended twice-a-day dose. Studies have shown that the antiviral activity of ZDV can continue in the body even after there does not appear to be any ZDV left in the blood. This occurs because the body breaks down the drug into substances that remain active against HIV. The body also breaks down 3TC, a drug that is combined with ZDV in the Combivir product, in a similar way. Since antiviral activity may continue after Combivir is removed from the body, it may not be necessary to take the drug as often as once thought. This study carefully measures levels of the active substances in order to find out whether the same amount of antiviral activity occurs with less-frequent dosing.

Conditions Studied

Interventions

  • DRUG Lamivudine/Zidovudine

Study Locations (20)

Illinois

  • Mt Sinai Hosp Med Ctr / Dept of Pediatrics - Chicago
  • Cook County Hosp - Chicago
  • Chicago Children's Memorial Hosp - Chicago

New York

  • Metropolitan Hosp Ctr - New York
  • State Univ of New York at Stony Brook - Stony Brook
  • SUNY Health Sciences Ctr at Syracuse / Pediatrics - Syracuse

California

  • Los Angeles County - USC Med Ctr - Los Angeles
  • Univ of California, San Diego - San Diego

New Jersey

  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp - Newark
  • St Joseph's Hosp & Med Center - Paterson

Pennsylvania

  • Children's Hosp of Philadelphia - Philadelphia
  • Temple University School of Medicine - Philadelphia

Florida

  • Univ of Florida Health Science Ctr / Pediatrics - Jacksonville

Georgia

  • Emory Univ Hosp / Pediatrics - Atlanta

Louisiana

  • Tulane Univ / Charity Hosp of New Orleans - New Orleans

Trial Details

FieldValue
Enrollment Target 20 participants
Est. Completion 2002-08
Phase Phase 1

What the Registry Record Tells You About NCT00014014

The ClinicalTrials.gov registry entry for NCT00014014 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Lamivudine/Zidovudine is the first listed.

NCT00014014 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Illinois, New York, California.

Frequently Asked Questions

What is clinical trial NCT00014014 about?

NCT00014014 is a clinical study titled "Zidovudine and Lamivudine Given Once Versus Twice Daily". The purpose of this study is to see if the full daily dose of Combivir (zidovudine \[ZDV\]/lamivudine \[3TC\]) taken once a day is as effective as the usual recommended twice-a-day dose. Studies have shown that the antiviral activity of ZDV can continue in the body even after there does not appear ...

What is the current status of trial NCT00014014?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. Estimated completion is 2002-08.

What conditions does trial NCT00014014 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00014014?

The interventions under investigation include: Lamivudine/Zidovudine (DRUG).

Who is sponsoring clinical trial NCT00014014?

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 NCT00014014 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Louisiana. 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.