START study

• Register: EUCTR
• Last refreshed on: 2 April 2024
• Main ID: EUCTR2008-006439-12-PT
• Date of registration: 27/01/2011
• Prospective Registration: Yes
• Primary sponsor: Regents of the University of Minnesota
• Public title: START study
• Scientific title: Strategic Timing of AntiRetroviral Treatment(START) - START
• Date of first enrolment: 05/08/2011
• Target sample size: 4000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006439-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: new strategy vs current guidelines Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Luxembourg, Malaysia, Mali, Mexico, Morocco, Nigeria, Norway, Peru, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Uganda, United Kingdom, United States

Key inclusion & exclusion criteria

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 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HIV Infection

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Trade Name: Truvada
Product Name: Truvada (tenofovir/emtricitabine) 200/245 mg
Pharmaceutical Form: Tablet
Other descriptive name: TENOFOVIR DISOPROXIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
INN or Proposed INN: EMTRICITABINE
CAS Number: 143491570
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Atripla
Product Name: Atripla (efavirenz/tenofovir/emtricitabine) 600/200/245 mg
Pharmaceutical Form: Tablet
Other descriptive name: TENOFOVIR DISOPROXIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
INN or Proposed INN: EMTRICITABINE
CAS Number: 143491570
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: EFAVIRENZ
CAS Number: 154598524
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-

Trade Name: Sustiva
Product Name: Sustiva (efavirenz) 600 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: EFAVIRENZ
CAS Number: 154598524
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-

Trade Name: Reyataz
Product Name: Reyataz (atazanavir) 300 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ATAZANAVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Trade Name: Norvir
Product Name: Norvir (ritonavir) 100mg
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: RITONAVIR
CAS Number: 155213675
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Kaletra
Product Name: Kaletra (lopinavir/ritonavir) 200/50 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: RITONAVIR
CAS Number: 155213675
Concentration unit: mg mi

Primary Outcome(s)

Primary end point(s): AIDS* or death from AIDS Opportunistic events consistent with the 1993 CDC expanded surveillance definition plus additional events associated with immunosuppression in the patient population targeted for enrollment. Esophageal candidiasis and chronic Herpes simplex infection will be counted as primary endpoints only if they result in death.Non-AIDSCVD: myocardial infarction, stroke, coronary revascularizationESRD: initiation of dialysis, renal transplantationDecompensated liver diseaseNon-AIDS-defining cancers, excluding basal and squamous cell skin cancers. Basal and squamous cell skin cancer will be counted as a primary endpoint only if they result in death.Death not attributable to AIDS, including death of unknown causeThe primary outcome of START and each of the major components of the primary outcome will be evaluated as the time to the first occurrence of an event above.

Secondary Objective: A)To compare early ART to deferred ART for each component of the prim. composite endpoint: AIDS* or death from AIDS, Non-AIDS or death not attributable to AIDS. B)To compare early ART to deferred ART for the following sec. outcomes:All-cause mortality, Non-AIDS,CVD,ESRD, Decomp.liver disease,Non-AIDS malign., AIDS, Bact. pneumonia, AEs, Hospitalization, QoL, Health-care utilization & care costs, HIV transmission risk behaviour, HIV drug resistance, Pulm. embolism or DVT, New-onset DM, CVD requiring treatment, CHF, PAD, Change in GFR and development of proteinuria, BP & blood lipids, ECG abnormalities, Use of BP or lipid-lowering treatment or aspirin, Change in neurocognitive function.C)To compare early ART with deferred ART for the primary/major outcomes in subgroups defined by the following at baseline:Age,Gender,Race/ethnicity,Presence & risk factor levels for SNA conditions,Baseline CD4 cell count & HIV RNA level, Geograph. region, enrolment date, ART regimen prior to randomization

Main Objective: To determine whether early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS* (AIDS with an asterisk include most traditional opportunistic conditions but exclude non-fatal esophageal candidiasis and chronic Herpes simplex) non-AIDS, or death from any cause

Secondary ID(s)

NCT00867048

INSIGHT001:STARTDAIDSID#10619

2008-006439-12-BE

Ethics review

Status: Approved
Approval date: 05/08/2011
Contact:

Results

• Results available: Yes
• Date Posted: 23/10/2023
• Date Completed: 27/07/2022
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-006439-12/results