Anti-HIV Medications for People Recently Infected With HIV
Completed · Phase 4
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00106171
- Run by
- Johns Hopkins Bloomberg School of Public Health
- People needed
- 113
- Starts
- 2005-05-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2023-09-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States
- University of British Columbia — Vancouver, British Columbia, Canada
- Sunnybrook Health Sciences Ctr. — Toronto, Ontario, Canada
- Canadian Immunodeficiency Research Collaborative (CIRC) Inc. — Toronto, Ontario, Canada
- CHUM - Hotel-Dieu — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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