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NCT00000753 · ClinicalTrials.gov registry record · Phase 1

A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC

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

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
6
Study locations

NCT00000753 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 30 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT00000753, 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
30 participants
Enrollment target
6
Study locations

Study Summary

To determine the safety, toxicity, pharmacokinetic profile, and antiretroviral activity of atevirdine mesylate ( U-87201E ) in HIV-infected patients. Per 06/04/93 amendment, to also evaluate the interactive effects of didanosine ( ddI ) or zalcitabine ( dideoxycytidine; ddC ) with zidovudine ( AZT ) on the pharmacokinetics of U-87201E and to assess the effects of the triple combination therapies on immunologic and virologic parameters. Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been associated with the rapid development of resistant HIV isolates, an initial evaluation of this drug in patients was made in combination with AZT. Because of the inability to detect resistance after 6 weeks of combined AZT/U-87201E therapy, this protocol will initially investigate U-87201E administered alone and then investigate the effect of this drug with AZT and ddI or ddC.

Conditions Studied

HIV Infections

Interventions

  • DRUG Zidovudine
  • DRUG Didanosine
  • DRUG Zalcitabine
  • DRUG Atevirdine mesylate

Study Locations (6)

Missouri

  • St. Louis ConnectCare, Infectious Diseases Clinic - St Louis
  • Washington U CRS - St Louis

California

  • USC CRS - Los Angeles

Florida

  • Univ. of Miami AIDS CRS - Miami

New York

  • Univ. of Rochester ACTG CRS - Rochester

Ohio

  • The Ohio State Univ. AIDS CRS - Columbus

Trial Details

FieldValue
Enrollment Target 30 participants
Est. Completion 1995-02
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00000753

The ClinicalTrials.gov registry entry for NCT00000753 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 (93% 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 4 interventions - of which Zidovudine is the first listed.

NCT00000753 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Missouri, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00000753 about?

NCT00000753 is a clinical study titled "A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC". To determine the safety, toxicity, pharmacokinetic profile, and antiretroviral activity of atevirdine mesylate ( U-87201E ) in HIV-infected patients. Per 06/04/93 amendment, to also evaluate the interactive effects of didanosine ( ddI ) or zalcitabine ( dideoxycytidine; ddC ) with zidovudine ( AZT )...

What is the current status of trial NCT00000753?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. Estimated completion is 1995-02.

What conditions does trial NCT00000753 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000753?

The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG), Zalcitabine (DRUG), Atevirdine mesylate (DRUG).

Who is sponsoring clinical trial NCT00000753?

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 NCT00000753 being conducted?

This trial has 6 study locations across California, Florida, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.