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NCT00000979 · ClinicalTrials.gov registry record · Phase 2

Comparison of ddI Versus Zidovudine in HIV-Infected Patients

A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
1,500
Enrollment target
20
Study locations

NCT00000979 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,500 participants, above the 443-participant average among 542 other HIV Infections trials with a reported enrollment target (239% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT00000979, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
1,500 participants
Enrollment target
20
Study locations

Study Summary

To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4 counts \< 200 cells/mm3. AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.

Conditions Studied

HIV Infections

Interventions

  • DRUG Zidovudine
  • DRUG Didanosine

Study Locations (20)

California

  • Children's Hosp of Los Angeles/UCLA Med Ctr - Los Angeles
  • Los Angeles County - USC Med Ctr - Los Angeles
  • Palo Alto Veterans Adm Med Ctr / Stanford Univ - Palo Alto
  • Univ of California / San Diego Treatment Ctr - San Diego
  • Stanford Univ School of Medicine - Stanford
  • Olive View Med Ctr - Sylmar
  • Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr - Sylmar
  • Harbor UCLA Med Ctr - Torrance

Illinois

  • Northwestern Univ Med School - Chicago
  • Cook County Hosp - Chicago
  • Rush Presbyterian - Saint Luke's Med Ctr - Chicago
  • Edward Hines Veterans Administration Hosp - Hines

Colorado

  • Mountain States Regional Hemophilia Ctr / Univ of Colorado - Denver
  • Univ of Colorado Health Sciences Ctr - Denver

District of Columbia

  • Whitman - Walker Clinic - Washington D.C.
  • George Washington Univ Med Ctr - Washington D.C.

Florida

  • G E Morey Jr - Fort Lauderdale
  • Univ of Miami School of Medicine - Miami

Indiana

  • Indiana Univ Hosp - Indianapolis

Kansas

  • Univ of Kansas School of Medicine - Wichita

Trial Details

FieldValue
Enrollment Target 1,500 participants
Phase Phase 2

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00000979

The ClinicalTrials.gov registry entry for NCT00000979 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 443-participant average among 542 other HIV Infections trials with a reported enrollment target (239% higher). 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 2 interventions - of which Zidovudine is the first listed.

NCT00000979 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Illinois, Colorado.

Frequently Asked Questions

What is clinical trial NCT00000979 about?

NCT00000979 is a clinical study titled "Comparison of ddI Versus Zidovudine in HIV-Infected Patients". To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4 counts \< 200 cells/mm3. AZT is effective in reducing mortality in patients with AIDS who receive the drug after the firs...

What is the current status of trial NCT00000979?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,500 participants.

What conditions does trial NCT00000979 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000979?

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

Who is sponsoring clinical trial NCT00000979?

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 NCT00000979 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. 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.