Strategic Timing of Antiretroviral Treatment

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Abbott; ANRS, Emerging Infectious Diseases; Bristol-Myers Squibb; Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS); German Federal Ministry of Education and Research; Gilead Sciences; GlaxoSmithKline; Medical Research Council; Merck Sharp & Dohme Corp.; National Cancer Institute (NCI); National Health and Medical Research Council, Australia; National Heart, Lung, and Blood Institute (NHLBI); National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Institute of Mental Health (NIMH); National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health Clinical Center (CC); NEAT - European AIDS Treatment Network; The Institute for Clinical Research at the Veterans Affairs Medical Center -- Washington, D.C., USA; The Kirby Institute for Infection and Immunity in Society; Tibotec Pharmaceutical Limited; Washington D.C. Veterans Affairs Medical Center
• Treatments: Anti-Retroviral Agents

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)