Anti-HIV Medications and Structured Treatment Interruptions for People Recently Infected With HIV
NCT00084032 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2012-10-29
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.
Conditions
- HIV Infections
Interventions
- BEHAVIORAL
-
Structured treatment interruption
Treatment interruption schedule is dependent on the Arm in which participants are enrolled in Step 2
- DRUG
-
Antiretroviral regimen
Participants will take any combination of FDA-approved ARV medications prescribed by their physician
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
Eric Rosenberg, MD · Massachusetts General Hospital
-
Don Smith, MB, ChB, MD · University of New South Wales, Australia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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