START study

Phase 1

• Conditions: HIV Infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2008-006439-12-NO
• Lead Sponsor: Regents of the University of Minnesota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-04
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Signed informed consent, HIV infection documented by plasma HIV RNA viral load, a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method such as a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry, Age > 18 years, Karnofsky performance score = 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 consecutive CD4+ cell counts > 500 cells/mm3 at least 2 weeks apart within 60 days before randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any previous use of ART or 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, History of decompensated liver disease, 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified