Status:
COMPLETED
Anti-HIV Medications for People Recently Infected With HIV
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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 progre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00106171
Start Date
May 1 2005
End Date
May 1 2012
Last Update
September 13 2023
Active Locations (5)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
University of British Columbia
Vancouver, British Columbia, Canada, V6Z2C7
3
Sunnybrook Health Sciences Ctr.
Toronto, Ontario, Canada, M4N 3M5 CA
4
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
Toronto, Ontario, Canada, M5B IL6