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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00581802
Eligibility Criteria:
Inclusion Criteria for Groups 1 and 3:
* HIV infected
* Antiretroviral therapy (ART) naive OR a history of treatment with highly active antiretroviral therapy (HAART), a currently detectable viral load greater than 500 copies/ml, about to begin second or later potentially suppressive antiretroviral regimen, and must meet the following two requirements:
1. Viral load less than 50 copies/ml on the immediately prior regimen with less than 50 copies/ml measured on at least two visits during prior ART
2. Viral load greater than 500 copies/ml on two consecutive visits and a history of failure during prior lamivudine- or emtricitabine-containing ART
Exclusion Criteria for Groups 1 and 3:
* History of treatment with any two of the following: darunavir, tipranavir, or enfuvirtide
* Self-reported or clinician-reported nonadherence to earlier ART
* Current substance abuse that, in the opinion of the investigator, will increase the risk of nonadherence
* Weight less than 110 lbs
* Blood transfusion within the 6 months prior to study entry
* Platelets less than 50 cells/mm3
* International normalized ratio (INR) greater than 2.0 if participants are on warfarin
* Heart disease with recent angina or myocardial infarction (MI) within 1 year prior to study entry
* Hematocrit 28% or less OR hemoglobin 8.0 g/dl or less
* Prior ART that included only one or two drugs
* Pregnancy
Inclusion Criteria for Groups 2 and 4:
* HIV infected
* Currently on HAART with an undetectable viral load of less than 50 copies/ml for 12 months prior to study entry (at least two measures). If the participant is on the second or later regimen of HAART, the previous regimen must have contained lamivudine or emtricitabine.
Exclusion Criteria:
* Viral load "blip" greater than 2,000 copies/ml during current suppressive regimen
* Consistent low level viral load (between 50 and 2,000 copies/ml) during current regimen
* Change in currently suppressing HAART before study entry
* Self-reported or clinician-reported nonadherence to earlier antiretroviral regimens
* Current substance abuse that, in the opinion of the investigator, will increase the risk of nonadherence
* Weight less than 110 lbs
* Blood transfusion within the 6 months prior to study entry
* Platelets less than 50 cells/mm3
* INR greater than 2.0 if participants are on warfarin
* Heart disease with recent angina or MI within 1 year prior to study entry
* Hematocrit 28% or less OR hemoglobin 8.0 g/dl or less
* Prior ART that included only one or two drugs
* Pregnancy
Inclusion Criteria for Group 5:
* HIV infected
* Currently taking or about to begin raltegravir with optimized background HAART
Exclusion Criteria:
* Current substance abuse that, in the opinion of the investigator, will increase the risk of nonadherence
* Weight less than 110 lbs
* Blood transfusion 6 months prior to study entry
* Platelets less than 50/mm3
* INR greater than 2.0 if participants are on warfarin
* Heart disease with recent angina or MI within 1 year prior to study entry
* • Hematocrit 28% or less OR hemoglobin 8.0 g/dl or less
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00581802
Study Brief:
Protocol Section:
NCT00581802