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NCT00002379 · ClinicalTrials.gov registry record · Phase 2

The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

A Phase 2 study of HIV Infections, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
100
Enrollment target
15
Study locations

NCT00002379 is a Phase 2 study of HIV Infections that has completed, run by Gilead Sciences. The registered enrollment target is 100 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (78% lower). The trial reports 15 study locations across 13 states.

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The verdict

NCT00002379, a Phase 2 study of HIV Infections, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
100 participants
Enrollment target
15
Study locations

Study Summary

To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.

Conditions Studied

Interventions

  • DRUG Lamivudine
  • DRUG Levocarnitine
  • DRUG Indinavir sulfate
  • DRUG Stavudine
  • DRUG Adefovir dipivoxil

Study Locations (15)

California

  • AIDS Healthcare Foundation Labs - Los Angeles
  • Davies Med Ctr - San Francisco

New York

  • Community Research Initiative on AIDS - New York
  • Saint Vincent's AIDS Ctr - New York

Arizona

  • Phoenix Body Positive - Phoenix

Connecticut

  • Blick Med Associates - Greenwich

District of Columbia

  • George Washington Med Ctr - Washington D.C.

Illinois

  • Cook County Gen Hosp / Division of Infect Diseases - Chicago

Maryland

  • Johns Hopkins Univ School of Medicine - Baltimore

Massachusetts

  • Community Research Initiative - Brookline

Trial Details

FieldValue
Enrollment Target 100 participants
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT00002379

The ClinicalTrials.gov registry entry for NCT00002379 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 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 (78% lower). The listed sponsor is Gilead Sciences, which has 504 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 Lamivudine is the first listed.

NCT00002379 reports 15 study locations spanning 13 distinct geographic areas - top geographies include California, New York, Arizona.

Frequently Asked Questions

What is clinical trial NCT00002379 about?

NCT00002379 is a clinical study titled "The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs". To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion ...

What is the current status of trial NCT00002379?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants.

What conditions does trial NCT00002379 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002379?

The interventions under investigation include: Lamivudine (DRUG), Levocarnitine (DRUG), Indinavir sulfate (DRUG), Stavudine (DRUG), Adefovir dipivoxil (DRUG).

Who is sponsoring clinical trial NCT00002379?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002379 being conducted?

This trial has 15 study locations across Arizona, California, Connecticut, District of Columbia, 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.