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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT00084032
Eligibility Criteria:
Note: Step 2, Arm 3 has been eliminated as of 12/13/04.
Inclusion Criteria for Step 1:
* Acute or early HIV infection as defined by the study
* Agrees to use acceptable methods of contraception
* Agrees to begin antiretroviral treatment regimen within 21 days of diagnosis and no more than 3 days after study entry
Exclusion Criteria for Step 1:
* Unwilling to follow random assignment in Step 2
* Abnormal laboratory result within 21 days prior to study entry, unless abnormality is considered part of acute HIV infection
* Have taken antiretroviral drugs other than for postexposure prophylaxis (PEP). Patients who have undergone up to 30 days of previous PEP treatment are not excluded.
* Pregnancy or breastfeeding
* Previous participation in an HIV vaccine trial
* Previous use of experimental therapeutic immunizations or cytokine infusions
Inclusion Criteria for Participants Enrolling Directly into Step 2:
* Viral load of less than 400 copies/ml
* Enrolled in the AIEDRP CORE01 study, with stored blood samples obtained within 21 days prior to starting treatment on CORE01
* Currently receiving antiretroviral treatment regimen, with no interruptions for more than 7 consecutive days since the beginning of treatment
* Antiretroviral treatment was started within 21 days after HIV diagnosis
* Agrees to use acceptable methods of contraception
Exclusion Criteria for Step 2:
* Unwilling to follow random assignment to study arms and follow scheduled treatment interruptions
* More than 52 weeks of ARV treatment since diagnosis of acute/early HIV infection prior to entering Step 2
* CD4 count less than 350 cells/mm3 within 28 days of entry into Step 2
* AIDS-defining illness
* Pregnant or breastfeeding
* Previous participation in an HIV vaccine trial
* Previous use of experimental therapeutic immunizations or cytokine infusions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00084032
Study Brief:
Protocol Section:
NCT00084032