Anti-HIV Medications for People Recently Infected With HIV
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Acute/Early Seroconverters, Acute Infection, Treatment Naive, Primary HIV Infection
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University
- University of British Columbia
- Sunnybrook Health Sciences Ctr.
- Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
- CHUM - Hotel-Dieu
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Immediate Treatment Arm
Deferred Treatment Arm
Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated.
Participants will receive no immediate HAART, but will receive HAART when HAART is clinically indicated.