A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic An… (NCT00000874) | Clinical Trial Compass
CompletedNot Applicable
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
United States148 participantsStarted 1997-08
Plain-language 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.
Who can participate
Age range
13 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000874
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)