Diseases and Conditions Researched
HIV Infection
What is the purpose of this trial?
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.
Participation Guidelines
Age: 18 Years and older
Gender: Both
Click here for
detailed participation information for this trial.
|
Sponsors:
|
National Institute of Allergy and Infectious Diseases (NIAID); University of Minnesota - Clinical and Translational Science Institute |
| Dates: |
March 20, 2009 |
| Last Updated: |
January 22, 2013 |
| Study HIC#: |
0903004868 |
| Clinicaltrials.gov ID: |
NCT00867048
|
Condition
HIV Infection
Intervention Details
| Drug:
|
All licensed antiretroviral medications |
Trial Phase
Phase 4
Trial Purpose
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.
Participation Guidelines
Age: 18 Years and older
Gender: Both
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)
Link
Publications
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Egger M, May M, Chêne G, Phillips AN, Ledergerber B, Dabis F, Costagliola D, D'Arminio Monforte A, de Wolf F, Reiss P, Lundgren JD, Justice AC, Staszewski S, Leport C, Hogg RS, Sabin CA, Gill MJ, Salzberger B, Sterne JA; ART Cohort Collaboration. Prognosis of HIV-1-infected patients starting highly active antiretroviral therapy: a collaborative analysis of prospective studies. Lancet. 2002 Jul 13;360(9327):119-29. Erratum in: Lancet 2002 Oct 12;360(9340):1178.
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May M, Sterne JA, Sabin C, Costagliola D, Justice AC, Thiébaut R, Gill J, Phillips A, Reiss P, Hogg R, Ledergerber B, D'Arminio Monforte A, Schmeisser N, Staszewski S, Egger M; Antiretroviral Therapy (ART) Cohort Collaboration. Prognosis of HIV-1-infected patients up to 5 years after initiation of HAART: collaborative analysis of prospective studies. AIDS. 2007 May 31;21(9):1185-97.
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Silverberg MJ, Neuhaus J, Bower M, Gey D, Hatzakis A, Henry K, Hidalgo J, Lourtau L, Neaton JD, Tambussi G, Abrams DI. Risk of cancers during interrupted antiretroviral therapy in the SMART study. AIDS. 2007 Sep 12;21(14):1957-63.
|
Sponsors:
|
National Institute of Allergy and Infectious Diseases (NIAID); University of Minnesota - Clinical and Translational Science Institute |
| Dates: |
March 20, 2009 |
| Last Updated: |
January 22, 2013 |
| Study HIC#: |
0903004868 |
| Clinicaltrials.gov ID: |
NCT00867048
|
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