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NCT00000882 · ClinicalTrials.gov registry record · Phase 2

Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects

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

Completed
Registry status
Phase 2
Development phase
300
Enrollment target
20
Study locations

NCT00000882 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 300 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00000882, 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
300 participants
Enrollment target
20
Study locations

Study Summary

To compare the proportion of patients in the 2 zidovudine (ZDV)-containing arms who have a plasma HIV RNA concentration below the limit of detection (defined as 500 copies/ml or less) at Weeks 20 and 24 \[AS PER AMENDMENT 8/24/98: HIV RNA concentration below the limit of detection is now defined as 200 copies/ml or less\]. To compare the safety and tolerability of the different treatment regimens. To compare the decrease in plasma HIV-1 RNA and the change in CD4 count from baseline to the average of Weeks 20 and 24 \[AS PER AMENDMENT 12/19/97: and to the average of Weeks 44 and 48; AS PER AMENDMENT 8/24/98: and the average of Weeks 88 and 96\] in the 2 ZDV-containing arms. To study the emergence of resistance to ZDV, lamivudine (3TC), stavudine (d4T), delavirdine (DLV), and indinavir (IDV) in treated patients. To correlate the antiviral and immunologic activity and emergence of drug resistance with pharmacologic parameters of study drugs. To delineate the pharmacokinetic interactions of IDV and DLV. \[AS PER AMENDMENT 12/19/97: To delineate the possible development of cellular resistance to nucleoside analogs and the consequences of switching nucleoside study drugs on intracellular phosphorylation.\] To document rates and patterns of adherence over the course of the study, from day of randomization through 48 weeks. \[AS PER AMENDMENT 8/24/98: To define long-term durability of the virologic activity of the different treatment regimens, as defined by the proportion of patients with plasma HIV-1 RNA levels that remains below the limit of detection. To define long-term tolerability of the different treatment regimens.\] Although a change in reverse transcriptase (RT) inhibitors is recommended when adding or changing protease inhibitors in a treatment regimen, the choice of available RT inhibitors is often limited by prior exposure, toxicity, or pharmacologic interaction with the protease inhibitors. This study addresses the question of whether to continue 3TC or substi

Conditions Studied

HIV Infections

Interventions

  • DRUG Zidovudine
  • DRUG Lamivudine
  • DRUG Indinavir sulfate
  • DRUG Stavudine
  • DRUG Delavirdine mesylate

Study Locations (20)

California

  • Univ of California / San Diego Treatment Ctr - San Diego
  • Stanford at Kaiser / Kaiser Permanente Med Ctr - San Francisco
  • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium - San Jose
  • San Mateo AIDS Program / Stanford Univ - Stanford
  • Stanford Univ Med Ctr - Stanford

Illinois

  • Northwestern Univ Med School - Chicago
  • Cook County Hosp - Chicago
  • Rush Presbyterian - Saint Luke's Med Ctr - Chicago
  • Louis A Weiss Memorial Hosp - Chicago

Hawaii

  • Queens Med Ctr - Honolulu
  • Univ of Hawaii - Honolulu

Maryland

  • State of MD Div of Corrections / Johns Hopkins Univ Hosp - Baltimore
  • Johns Hopkins Hosp - Baltimore

Alabama

  • Univ of Alabama at Birmingham - Birmingham

Colorado

  • Univ of Colorado Health Sciences Ctr - Denver

Florida

  • Univ of Miami School of Medicine - Miami

Indiana

  • Indiana Univ Hosp - Indianapolis

Trial Details

FieldValue
Enrollment Target 300 participants
Phase Phase 2

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00000882

The ClinicalTrials.gov registry entry for NCT00000882 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 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 (33% 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 5 interventions - of which Zidovudine is the first listed.

NCT00000882 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Illinois, Hawaii.

Frequently Asked Questions

What is clinical trial NCT00000882 about?

NCT00000882 is a clinical study titled "Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects". To compare the proportion of patients in the 2 zidovudine (ZDV)-containing arms who have a plasma HIV RNA concentration below the limit of detection (defined as 500 copies/ml or less) at Weeks 20 and 24 \[AS PER AMENDMENT 8/24/98: HIV RNA concentration below the limit of detection is now defined as ...

What is the current status of trial NCT00000882?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants.

What conditions does trial NCT00000882 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000882?

The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Indinavir sulfate (DRUG), Stavudine (DRUG), Delavirdine mesylate (DRUG).

Who is sponsoring clinical trial NCT00000882?

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 NCT00000882 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Hawaii. 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.