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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT00298350
Eligibility Criteria:
Inclusion Criteria:
* HIV RNA greater than or equal to 1000 c/mL.
* Failed/Failing protease inhibitor based antiretroviral therapy.
* Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.
* Negative Serum Pregnancy Test.
* GFR by Cockcroft Gault greater than or equal to 80 mL/min.
* AST \& ALT less than or equal to 2.5x ULN.
* Total Bilirubin less than or equal to 1.5 mg/dL.
* Albumin greater than 3.5 mg/dL.
* Prothrombin Time INR 1.0-1.4
* Platelets greater than or equal to 50,000.
* Hemoglobin greater than or equal to 8.0 mg/dL.
* Absolute Neutrophil Count greater than or equal to 1000.
Exclusion Criteria:
* New AIDS defining condition within 30 days of baseline.
* Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).
* Ascites or encephalopathy.
* Breast Feeding.
* Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00298350
Study Brief:
Protocol Section:
NCT00298350