Strategic Timing of Antiretroviral Treatment
Condition: HIV Infection
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: All licensed antiretroviral medications
Intervention description: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Intervention MeSH terms: Anti-Retroviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4688.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: highly active antiretroviral therapy (HAART); CD4 Count; Early Intervention; HIV; HIV Infection; HIV Infections; treatment naive

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 count is still fairly high, instead of waiting until the CD4+ count is at
           the level where there is good evidence for starting medicines.

        -  To learn more about how a strategy of starting HIV medicines early might affect other
           aspects of care, such as the chances of developing other illnesses or resistance to HIV
           medicines, the frequency of doctor visits, the cost of medical care, and general health
           and satisfaction.
    

Eligibility criteria:

        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)