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

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000874

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

148

Starts

1997-08-01

Expected to finish

1999-03-01

Last updated by the study team

2013-10-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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].

You may not qualify if…

• 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].

Where it is running

• Community Consortium / UCSF — San Francisco, California, United States
• Community Consortium of San Francisco — San Francisco, California, United States
• Alpine Family Medicine / Janowski — Denver, Colorado, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• S Denver Infectious Diseases Specialists — Denver, Colorado, United States
• VA Med Ctr — Denver, Colorado, United States
• Montgomery County Health Dept — Washington D.C., District of Columbia, United States
• Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Wayne State Univ / WSU / DMC HIV / AIDS Program — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Mercer Area Early Intervention Services — Camden, New Jersey, United States
• Southern New Jersey AIDS Cln Trials / Dept of Med — Camden, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Partners in Research / New Mexico — Albuquerque, New Mexico, United States
• Partners Research — Albuquerque, New Mexico, United States
• T A Ferrill Regional HIV Clinic — Albuquerque, New Mexico, United States
• Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
• The Research and Education Group — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Saint Joseph's Hosp — Philadelphia, Pennsylvania, United States
• Richmond AIDS Consortium — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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