Strategic Timing of Antiretroviral Treatment

Completed · Phase 4

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT00867048

Run by

University of Minnesota

People needed

4688

Starts

2009-04-15

Expected to finish

2022-07-27

Last updated by the study team

2024-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• The Research + Education Group - Portland — Portland, Oregon, United States
• The Research and Education Group at Portland VA Research Foundation — Portland, Oregon, United States
• Temple University — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• UT Southwestern Clinical Research Unit — Dallas, Texas, United States
• University of North Texas Health Science Center — Fort Worth, Texas, United States
• Houston AIDS Research Team — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• San Antonio Military Health System — San Antonio, Texas, United States
• Naval Medical Center Portsmouth — Portsmouth, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• AIDS Resource Center of Wisconsin — Milwaukee, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Hospital Nacional Profesor Alejandro Posadas — El Palomar, Buenos Aires, Argentina
• Hospital Interzonal General de Agudos Dr. Diego Paroissien — Isidro Casanova, Buenos Aires, Argentina
• CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral) — Rosario, Santa Fe Province, Argentina
• FUNCEI — Buenos Aires, Argentina
• Fundacion IDEAA — Buenos Aires, Argentina
• Hospital General de Agudos JM Ramos Mejia — Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• Hospital Rawson — Córdoba, Argentina
• CEIN — Neuquén, Argentina
• Burwood Road General Practice — Burwood, New South Wales, Australia
• East Sydney Doctors — Darlinghurst, New South Wales, Australia
• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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