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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

NCT00000874 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2013-10-01

No results posted yet for this 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.

Conditions

  • HIV Infections

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Baxter J

  • Mayers D

  • Merigan T

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-08-31
Primary Completion
1999-01-31
Completion
1999-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000874 on ClinicalTrials.gov