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NCT00000874 · ClinicalTrials.gov registry record

A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART

A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
148
Enrollment target

NCT00000874 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 148 participants.

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The verdict

NCT00000874 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
148 participants
Enrollment target

Study Summary

To determine the short-term virologic and immunologic effects of using plasma genotypic antiretroviral resistance testing (GART) results (interpreted by study virologists AS PER AMENDMENT 9/17/97) in the management of therapy for antiretroviral-experienced patients failing on one of the following regimens: 1. zidovudine (ZDV) + (lamivudine) 3TC + (indinavir) IDV 2. ZDV + 3TC + saquinavir (SQV) 3. ZDV + 3TC + ritonavir (RTV) 4. stavudine (d4T) + 3TC + IDV. \[AS PER AMENDMENT 11/26/97: To determine the short-term effects of using plasma GART in the management of antiretroviral-experienced patients failing on a triple drug regimen that includes a single protease inhibitor (indinavir \[IDV\], saquinavir \[SQV\], ritonavir \[RTV\], or nelfinavir \[NFV\]) and two licensed nucleoside reverse transcriptase inhibitors (NRTIs).\] A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death. All commercially available antiretrovirals and many of those in development have been associated with resistance. Fortunately, techniques are available to define HIV genotypic resistance in "real time" as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting. Using genotypic antiretroviral resistance testing (GART) results, along with other currently available markers, may lead to improved treatment decisions compared with using currently available markers alone.

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 1997-08
Est. Completion 1999-03

What the Registry Record Tells You About NCT00000874

The ClinicalTrials.gov registry entry for NCT00000874 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 148 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 0 interventions.

NCT00000874 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000874 about?

NCT00000874 is a clinical study titled "A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART". To determine the short-term virologic and immunologic effects of using plasma genotypic antiretroviral resistance testing (GART) results (interpreted by study virologists AS PER AMENDMENT 9/17/97) in the management of therapy for antiretroviral-experienced patients failing on one of the following re...

What is the current status of trial NCT00000874?

This trial is currently completed. The enrollment target is 148 participants. The study started on 1997-08. Estimated completion is 1999-03.

Who is sponsoring clinical trial NCT00000874?

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

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