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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00041769
Eligibility Criteria:
Note: Enrollment into Arm C closed on 07/28/04 after reaching target accrual. Participants with a Week 2 NIQ of greater than 1 will be permanently discontinued from the study.
Inclusion Criteria for Step 1:
* HIV infected
* Viral load of 1000 copies/ml or more at study screening
* At least one viral load of 400 copies/ml or more within 6 months of study entry while on the failing antiretroviral regimen
* Virologic failure of at least one combination (two or more drugs) antiretroviral regimen, with at least one of these failing regimens containing a PI. Low dose ritonavir and hydroxyurea are not counted as antiretrovirals.
* Currently on a failing combination antiretroviral regimen
* Plan to initiate a salvage regimen containing a PI within 7 days of study entry
* Acceptable methods of contraception while receiving the study medications and for 6 weeks after stopping the medications. Participants who are currently taking efavirenz and who have undergone surgery to prevent conception (e.g., hysterectomy, tubal ligation, vasectomy) must provide physician's documentation of their current regimen and of their previous surgery.
* Resistance to at least one drug in the failing regimen, documented within 90 days of study entry
* Karnofsky performance scale of 70 or more within 30 days prior to study entry
Exclusion Criteria:
* Growth factors, interleukins, interferons (except for the treatment of hepatitis C), non-FDA approved systemic drugs, and HIV vaccines within 30 days of study entry
* Require certain medications prior to or during the study
* Certain heart conditions, if starting a PI-based regimen as the salvage regimen
* Acute illness or infection requiring treatment within 14 days of study entry
* Any condition that would limit ability to participate in the study
* Cancer requiring radiation or systemic chemotherapy
* Active drug or alcohol use or dependence that would interfere with the ability to meet study requirements
* Acute or chronic pancreatitis
* Planned use of hydroxyurea in the salvage regimen
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00041769
Study Brief:
Protocol Section:
NCT00041769