A Randomized Trial of HAART in Acute/Early HIV Infection

1R01AI056990-01A1

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.

2005-05-01

2012-05-01

2012-05-01

Completed

Early phase I

113

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 113, 'type': 'ACTUAL'}}

2023-09-13