Anti-HIV Medications and Structured Treatment Interruptions for People Recently Infected With HIV
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acute Infection, Treatment Interruption, Treatment Naive, Primary HIV Infection, PHI
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
In Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks.
In Step 1, participants will receive ARV therapy for 24 weeks. Upon entering Step 2, participants will stop ARVs for 4 weeks, take ARVs for 8 weeks, stop ARVs for 4 weeks, take ARVs for 8 weeks, and then stop ARVs for 56 weeks.