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NCT00000861 · ClinicalTrials.gov registry record · NA

The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients

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

Completed
Registry status
NA
Development phase
1,900
Enrollment target

NCT00000861 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,900 participants.

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The verdict

NCT00000861, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
1,900 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effect of immediate versus deferred indinavir (IDV) in addition to background therapy on disease progression or death in patients with CD4+ cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels \>= 10,000 copies/ml. This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients.

Interventions

  • DRUG Indinavir sulfate

Trial Details

FieldValue
Enrollment Target 1,900 participants
Est. Completion 1997-03
Phase NA

What the Registry Record Tells You About NCT00000861

The ClinicalTrials.gov registry entry for NCT00000861 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,900 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 1 intervention - of which Indinavir sulfate is the first listed.

NCT00000861 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000861 about?

NCT00000861 is a clinical study titled "The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients". The purpose of this study is to evaluate the effect of immediate versus deferred indinavir (IDV) in addition to background therapy on disease progression or death in patients with CD4+ cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels \>= 10,000 copies/ml. This study aims to exami...

What is the current status of trial NCT00000861?

This trial is currently completed. It is a NA study. The enrollment target is 1,900 participants. Estimated completion is 1997-03.

What interventions are being tested in trial NCT00000861?

The interventions under investigation include: Indinavir sulfate (DRUG).

Who is sponsoring clinical trial NCT00000861?

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.