Anti-HIV Medications and Structured Treatment Interruptions for People Recently Infected With HIV

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 medications. The purpose of this study is to see if giving anti-HIV medications to people soon after they have been infected with HIV can help them control HIV. The study will also see if the immune system can control the amount of HIV virus in the blood (viral load) even after a person has stopped taking the medications. The study will evaluate three different schedules of stopping and starting anti-HIV medications to see which schedule is best able to boost a patient's immune system to control HIV viral load.

Hypothesis: Combination therapy started in primary HIV infection, in conjunction with structured treatment interruptions, will result in greater control of viremia off treatment than induction therapy alone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents

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