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NCT00002389 · ClinicalTrials.gov registry record · Phase 3

The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used With and Without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

A Phase 3 study of HIV Infections, sponsored by Glaxo Wellcome.

Completed
Registry status
Phase 3
Development phase
210
Enrollment target
15
Study locations

NCT00002389 is a Phase 3 study of HIV Infections that has completed, run by Glaxo Wellcome. The registered enrollment target is 210 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (53% lower). The trial reports 15 study locations across 12 states.

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The verdict

NCT00002389, a Phase 3 study of HIV Infections, has completed, sponsored by Glaxo Wellcome.

COMPLETED
Registry status
Phase 3
Development phase
210 participants
Enrollment target
15
Study locations

Study Summary

To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion of subjects with viral load \< 400 copies/ml, plasma HIV-1 RNA profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.

Conditions Studied

Interventions

  • DRUG Zidovudine
  • DRUG Lamivudine
  • DRUG Abacavir sulfate

Study Locations (15)

California

  • East Bay AIDS Ctr - Berkeley
  • Kraus Med Partners - Los Angeles

New York

  • St Vincent's Hosp and Med Ctr / AIDS Ctr - New York
  • Harlem Hosp - New York

Texas

  • Dr Nicholaos Bellos - Dallas
  • Baylor College of Medicine / Dept of Medicine - Houston

District of Columbia

  • Georgetown Univ Med Ctr - Washington D.C.

Florida

  • Univ of Miami Dept of Medicine - Miami

Illinois

  • Rush Med College / Rush Presbyterian - St Luke's Med Cen - Chicago

Massachusetts

  • Boston Med Ctr / Evans - 556 - Boston

New Jersey

  • Saint Michael's Med Ctr / Dept of Infectious Diseases - Newark

Trial Details

FieldValue
Enrollment Target 210 participants
Phase Phase 3

Sponsor

Glaxo Wellcome

65 total trials

What the Registry Record Tells You About NCT00002389

The ClinicalTrials.gov registry entry for NCT00002389 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (53% lower). The listed sponsor is Glaxo Wellcome, which has 65 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Zidovudine is the first listed.

NCT00002389 reports 15 study locations spanning 12 distinct geographic areas - top geographies include California, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT00002389 about?

NCT00002389 is a clinical study titled "The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used With and Without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs". To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion o...

What is the current status of trial NCT00002389?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 210 participants.

What conditions does trial NCT00002389 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002389?

The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Abacavir sulfate (DRUG).

Who is sponsoring clinical trial NCT00002389?

This trial is sponsored by Glaxo Wellcome, which has 65 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002389 being conducted?

This trial has 15 study locations across California, District of Columbia, Florida, Illinois, Massachusetts. 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 Editorial

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.