Anti-HIV Medications for People Recently Infected With HIV

Study Overview
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Brief Summary
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It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV. Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.

Detailed Description
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Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in slower progression of HIV disease. This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy (HAART) with those who receive no treatment. This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion (acute seroconverters) with patients who enroll within 3 to 12 months of seroconversion (early seroconverters). This study will last at least 3 years. Participants will be randomly assigned to one of two groups. Group 1 will receive HAART for 1 year; Group 2 will receive no treatment. There will be at least 20 study visits over the 3-year study period. Blood collection will occur at all study visits. A physical exam, medical and medication history, and risk behavior assessment will occur at most visits; participants will also be asked to complete an adherence questionnaire at most visits.

Official Title
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A Randomized Trial of HAART in Acute/Early HIV Infection

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Highly active antiretroviral therapy (HAART)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented acute or recent HIV infection (infected in the past 12 months) as defined in the study protocol Antiretroviral naive. Participants who have taken antiretrovirals for postexposure prophylaxis are eligible for this study. Able to swallow tablets or capsules Willing to use acceptable forms of contraception Exclusion Criteria: Physician unable to design a potentially effective HAART regimen based on results of genotypic resistance testing Two CD4 counts of less than 350 cells/mm3 obtained at least 7 days apart within 30 days of study entry Viral load less than 5,000 copies/ml within 30 days of study entry in participants who have been infected with HIV-1 for more than six months prior to study entry Use of systemic cancer chemotherapy, systemic investigational agents, specific antiretroviral medications, or immunomodulators (growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons) within 30 days prior to study entry Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study Serious illness requiring systemic treatment or hospitalization until participant either completes therapy or is clinically stable on therapy for at least 7 days prior to study entry Currently involuntarily incarcerated for treatment of either a psychiatric or physical (e.g., infectious disease) illness Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment Arm<br>Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated. | Drug: Highly active antiretroviral therapy (HAART)<br>* Regimens will be assigned by investigators<br>|
| No Intervention: Deferred Treatment Arm<br>Participants will receive no immediate HAART, but will receive HAART when HAART is clinically indicated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Treatment-free Time to Initiation of Permanent HAART | All HAART-free time from initial infection with HIV to initiation of permanent HAART | Through study completion, an average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as Assessed by the of Number of Participants With Serious Adverse Events | Number of participants with serious adverse events (grade 3 or 4 as defined by the NIH toxicity scale) | Throughout study completion, an average of 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Acute/Early Seroconverters, Acute Infection, Treatment Naive, Primary HIV Infection