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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00084032 |
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.
Condition | Intervention |
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HIV Infections |
Behavioral: Structured treatment interruption Drug: Antiretroviral regimen |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Multicenter Trial to Determine Whether Induction Therapy Followed by Treatment Interruption is Superior to Induction Therapy Alone in the Treatment of Primary HIV Infection (PHI): The Structured Treatment Interruption (STI) Study |
Estimated Enrollment: | 120 |
Study Start Date: | September 2009 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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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
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2: Experimental
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.
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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
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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. However, it is difficult for patients treated during acute infection to maintain long-term continuous antiretroviral (ARV) treatment because of difficulty adhering to complicated medication regimens, drug-related toxicities, and cost of medications. Acutely infected patients who have undergone early initiation of treatment followed by structured treatment interruptions (STIs) appear to have lower off-treatment viral loads than historical controls. This study will evaluate whether effective ARV treatment during acute and early HIV infection followed by STI will result in lower viral setpoints than would otherwise be expected.
This trial will have 2 steps and will last for a maximum of 104 weeks. Participants will either enter Step 1 and continue on to Step 2 or enter Step 2 directly. During Step 1, participants with acute or early HIV infection will be given 24 weeks of ARV therapy. Participants may take any combination of FDA-approved ARV medications that they and their doctors select. Participants will have study visits at study entry and Weeks 1, 4, 8, and 20. After 24 weeks on Step 1, participants may enroll in Step 2.
Participants in Step 1 and people with early or acute HIV infection who began ARV treatment within 21 days of diagnosis and have had no more than 1 year of treatment may enroll in Step 2. During Step 2, participants will be randomly assigned to one of two study arms:
Participants in both study arms will restart ARVs regardless of STI duration if their viral load is above 50,000 copies/ml, they progress to CDC category C disease, or their CD4 count falls below 350 cells/mm3 or declines more than 50% from the last on-treatment CD4 level.
Step 2 will last 80 weeks. For the first year, participants will have study visits every 1 to 4 weeks, depending on whether they are taking ARVs. During the second year, participants will have study visits every 8 weeks. Study visits will include a brief medical history, blood and pregnancy tests, and voluntary behavioral questionnaires.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Note: Step 2, Arm 3 has been eliminated as of 12/13/04.
Inclusion Criteria for Step 1:
Exclusion Criteria for Step 1:
Inclusion Criteria for Participants Enrolling Directly into Step 2:
Exclusion Criteria for Step 2:
Australia | |
St. Vincents Hospital | |
Darlinghurst, Australia, NSW2010 | |
Burwood Road Practice | |
Burwood, Australia, NSW 2134 | |
Taylor Square Private Clinic | |
Darlinghurst, Australia, NSW -2010 | |
Holdsworth House General Practice | |
Darlinghurst, Australia, NSW 2010 | |
AIDS Research Initiative | |
Darlinghurst, Australia, NSW 2010 | |
407 Doctors | |
Surry Hills, Australia, NSW 2010 |
Study Chair: | Eric Rosenberg, MD | Massachusetts General Hospital |
Study Chair: | Don Smith, MB, ChB, MD | University of New South Wales, Australia |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | AIEDRP AIN502 |
Study First Received: | June 4, 2004 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00084032 |
Health Authority: | United States: Federal Government |
Acute Infection Treatment Interruption Treatment Naive Primary HIV Infection PHI |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |