Search / Trial NCT00000874

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Hiv 1 Drug Therapy, Combination Zidovudine Stavudine Drug Resistance, Microbial Hiv Protease Inhibitors Cd4 Lymphocyte Count Ritonavir Lamivudine Indinavir Rna, Viral Genotype Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

Description

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 decision...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Documentation of a CD4+ cell count between 50 and 500/mm3 prior to the baseline visit [within 6 weeks prior to baseline visit AS PER AMENDMENT 9/17/97].
  • Documentation of either a plasma HIV RNA > 50,000 copies/ml by the Roche Amplicor HIV-1 assay or > 25,000 copies/ml by the Chiron bDNA assay, performed within 30 days prior to the baseline visit. [AS PER AMENDMENT 9/17/97: Documentation of either a plasma HIV RNA level >20,000 copies/ml by the Roche Amplicor HIV-1 assay or >10,000 copies/ml by the Chiron bDNA assay, performed within 6 weeks prior to baseline visit.]
  • Documentation of a 3-fold rise in plasma HIV RNA level (using the same assay) or a previously documented plasma HIV RNA at an undetectable level while on the current antiretroviral regimen. [AS PER AMENDMENT 9/17/97: Documentation that the screening plasma HIV RNA level is a 3-fold rise from a previous determination (using the same assay) or documentation of a previous plasma HIV RNA <500 copies/ml while on the current antiretroviral regimen.]
  • Signed, informed consent from a parent or legal guardian for patients < 18 years of age.
  • Prior Medication: Included:
  • At least an 18-month cumulative history of antiretroviral therapy [AS PER AMENDMENT 9/17/97: At least a 12-month cumulative history of antiretroviral therapy].
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions are excluded:
  • Intercurrent illness (which in the clinician's judgment could influence the HIV RNA level) within 2 weeks prior to, or since, obtaining blood for the screening HIV RNA measurement [within 2 weeks prior to obtaining screening HIV RNA specimen or within 2 weeks prior to baseline visit AS PER AMENDMENT 11/26/97].
  • Unwillingness or inability to change antiretroviral therapy.
  • Unwillingness to wait up to 30 days after the GART baseline visit to change current triple treatment therapy regimen [AS PER AMENDMENT 9/17/97: Unwillingness to wait until baseline plasma GART results are available to change the current triple therapy regimen].
  • Accessibility to previous genotypic or phenotypic resistance testing results.
  • Co-enrollment in a clinical trial with anti-HIV drugs.
  • Concurrent Medication:
  • Excluded:
  • Agents with anti-HIV activity.
  • Initiation of treatment with IL-2, interferon, or adefovir dipivoxil.
  • Anti-influenza or other vaccines.
  • Prior Medication:
  • Excluded:
  • [AS PER AMENDMENT 11/26/97:
  • Use of immunomodulators within 2 weeks prior to obtaining the screening plasma HIV RNA specimen or within 2 weeks prior to the baseline visit.
  • Use of any anti-HIV agents, other than drugs in the qualifying triple antiretroviral regimen, within the past 16 weeks.]
  • Patients must currently be on one of the following triple antiretroviral regimens for at least 16 weeks:
  • ZDV + 3TC + IDV
  • ZDV + 3TC + SQV
  • ZDV + 3TC + RTV
  • d4T + 3TC + IDV. [AS PER AMENDMENT 11/26/97: Patients must currently be on a triple antiretroviral regimen that includes a single protease inhibitor (IDV, SQV, RTV, or NFV) and two licensed NRTIs for at least 16 weeks.]
  • Concurent Treatment: Excluded:
  • Vaccination within 2 weeks prior to, or since, obtaining blood for the screening HIV RNA measurement [within 2 weeks prior to obtaining screening plasma HIV RNA specimen or within 2 weeks prior to the baseline visit AS PER AMENDMENT 11/26/97].

Attachments

readout_NCT00000874_2024-05-23.pdf

4.5 MB

NCT00000874_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Francisco, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Camden, New Jersey, United States

Newark, New Jersey, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Richmond, Virginia, United States

San Francisco, California, United States

Albuquerque, New Mexico, United States

Camden, New Jersey, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Denver, Colorado, United States

Denver, Colorado, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Detroit, Michigan, United States

Albuquerque, New Mexico, United States

Albuquerque, New Mexico, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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