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:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT00011128
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are HIV-infected.
* Are likely to have drug-resistant HIV from having taken all types of anti-HIV drugs (protease inhibitors \[PIs\], nucleoside reverse transcriptase inhibitors \[NRTIs\], and nonnucleoside reverse transcriptase inhibitors \[NNRTIs\]), and having failed treatment prior to the current treatment for reasons other than toxicity.
* Are currently receiving anti-HIV treatment with at least 3 drugs. Low doses of ritonavir (100 to 200 mg twice daily) taken with 1 other PI is counted as a single PI.
* Are currently failing treatment due to a high viral load (amount of HIV in the blood).
* Have had a new anti-HIV drug combination selected.
* Are at least 18 years old.
* This study has been changed to remove CD4 counts as an inclusion criterion. In the previous version of the protocol, patients were required to have a CD4 count of 150 cells/ml or more within 42 days prior to study entry.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Have stopped treatment for more than 4 weeks in the past 6 months.
* Are pregnant or breast-feeding.
* Have cancer that requires systemic treatment or radiation.
* Have received the following medications affecting the immune system within 14 days before entry: erythropoietin; Granulocyte Colony Stimulating Factor (G-CSF), including Granulocyte Macrophage Colony Stimulating Factors (GM-CSF); interleukins; or therapeutic HIV vaccines.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00011128
Study Brief:
Protocol Section:
NCT00011128