Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00188851
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years.
* On therapy with a triple ARV that includes a protease inhibitor and/or non-nucleoside reverse transcriptase inhibitor for the past 3 months with no changes in any agent of the combination in the past 14 days.
* Virologic failure while on the combination as defined by a plasma HIV RNA \> 1000 copies/mL measured on 2 occasions at least 4 weeks apart.
* HIV RNA \<500,000 copies/mL.
* CD4 cell count must be \> 50/mm3
* Patients must not have a present history of opportunistic infections or acute illness requiring treatment within the preceding 30 days.
* The patient has at least two new ARV available based on history, and at least two of these new agents will be included in the new salvage regimen.
Exclusion Criteria:
* Active substance abuse which would interfere with the patient's ability to participate in this trial, or declared non-compliance.
* Pregnancy or breast feeding.
* Patients with any of the following abnormal laboratory test results at screening:· Hemoglobin\<80 g/L, neutrophil count\<750 cells/mL, Platelet\<20,000 /mL· AST or ALT \> 5X Upper Limit of Normal (ULN)· Creatinine \> 250 umol/L
* End stage organ disease
* Patient with malignancy receiving systemic chemotherapy
* Patient has need for immune modulators (interleukin, interferon, GMCSF etc) or prednisone. This excludes a short course of inhaled or oral steroids for asthma exacerbation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00188851
Study Brief:
Protocol Section:
NCT00188851