Status:
COMPLETED
Strategic Timing of Antiretroviral Treatment
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Objectives: * To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell...
Detailed Description
Background: * Most guidelines agree that if the number of your CD4+ cells (cells in your blood which help fight infection) drops below 350 cells/mm3, or if you have symptoms of AIDS, you should start...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Signed informed consent
- HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed\* ELISA test; and confirmed by another test using a different method including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
- Age greater than or equal to 18 years
- Karnofsky performance score greater than or equal to 80 (an indication that the participant can perform normal activities)
- Perceived life expectancy of at least 6 months
- For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed
- Two CD4+ cell counts greater than 500 cells/mm(3) at least 2 weeks apart within 60 days before randomization
- The term licensed refers to an FDA-approved kit or, for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country. Confirmation of the initial test result must use a test method that is different than the one used for the initial assessment.
- EXCLUSION CRITERIA:
- Any previous use of ART or interleukin-2 (IL-2)
- Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection)
- Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever
- Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization
- Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization
- Dialysis within 6 months before randomization
- Diagnosis of decompensated liver disease before randomization
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness
- Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential)
Exclusion
Key Trial Info
Start Date :
April 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2022
Estimated Enrollment :
4688 Patients enrolled
Trial Details
Trial ID
NCT00867048
Start Date
April 15 2009
End Date
July 27 2022
Last Update
March 4 2024
Active Locations (218)
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1
University of Southern California
Alhambra, California, United States, 91803
2
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
3
UCLA CARE-4-Families (LABAC CRS)
Los Angeles, California, United States, 90095
4
UCSD Mother-Child-Adolescent Program
San Diego, California, United States, 92103