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NCT00000831 · ClinicalTrials.gov registry record · Phase 2

Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

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

Completed
Registry status
Phase 2
Development phase
280
Enrollment target

NCT00000831 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 280 participants.

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The verdict

NCT00000831, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
280 participants
Enrollment target

Study Summary

To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI. Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.

Interventions

  • DRUG Zidovudine
  • DRUG Lamivudine
  • DRUG Stavudine
  • DRUG Didanosine

Trial Details

FieldValue
Enrollment Target 280 participants
Est. Completion 1998-05
Phase Phase 2

What the Registry Record Tells You About NCT00000831

The ClinicalTrials.gov registry entry for NCT00000831 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.

NCT00000831 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000831 about?

NCT00000831 is a clinical study titled "Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy". To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifical...

What is the current status of trial NCT00000831?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 280 participants. Estimated completion is 1998-05.

What interventions are being tested in trial NCT00000831?

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

Who is sponsoring clinical trial NCT00000831?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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.