Status:
WITHDRAWN
Anti-HIV Medications and Structured Treatment Interruptions for People Recently Infected With HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
People recently infected with HIV who are treated with anti-HIV medications may develop strong immune system responses to HIV and may be able to control the virus without continuing to take these medi...
Detailed Description
Initiation of treatment during acute HIV infection seems to result in greater suppression of viral replication than noted during chronic infection and better recovery of certain CD4 subpopulations. Ho...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00084032
Last Update
October 29 2012
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