Anti-HIV Medications for People Recently Infected With HIV

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents

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