Status:
COMPLETED
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare...
Detailed Description
About 6 months after infection, HIV viral load reaches a temporarily stable level known as virus set point. Virus set point is different for each patient and can be a predictor for disease progression...
Eligibility Criteria
Inclusion
- Acute or recent HIV-1 infection. More information about this criterion can be found in the protocol.
- CD4 count 500 cells/mm3 or greater
- No evidence of prior or current AIDS-defining illness
- No signs or symptoms of HIV infection or AIDS-defining illness that, in the opinion of the investigator, requires ART
- Willing to use acceptable forms of contraception
Exclusion
- Prior treatment with any antiretroviral drug for more than 7 days
- Use of certain drugs within 21 days of study entry
- Prior receipt of investigational anti-HIV-1 vaccine
- Ongoing therapy with systemic corticosteroids, chemotherapeutic agents, nephrotoxic systemic agents, immunomodulatory treatments, or investigational agents
- Known allergy/sensitivity to study drugs or their formulations
- Current drug or alcohol use or abuse that, in the opinion of the investigator, may interfere with the study
- Serious medical or psychiatric illness that may interfere with the study
- Hepatitis B infected
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00414518
Start Date
January 1 2007
End Date
February 1 2010
Last Update
February 20 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
2
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
3
University of Zimbabwe College of Health Sciences
Harare, Zimbabwe