START study

Strategic Timing of AntiRetroviral Treatment(START) - START

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006439-12-BE

Enrollment

4600

Registered

2009-03-04

Start date

2009-05-25

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Interventions

Trade Name: Truvada Product Name: Truvada (tenofovir/emtricitabine) 200/245 mg Pharmaceutical Form: Tablet Other descriptive name: TENOFOVIR DISOPROXIL Concentration unit: mg milligram(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All HIV-positive participants in START are eligible to continue in extended follow-up 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 4590 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
Main Objective: Based on two scientific hypotheses, both which take advantage of the randomized design of START and the extended follow-up through 2021, the primary objective is to determine whether the benefit of early ART as compared to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS, non-AIDS, or death from any cause is maintained, increased or reduced.;Secondary Objective: To compare early ART to deferred ART for the following secondary outcomes: All-cause mortality, ESRD (initiation of dialysis, renal transplantation), Decompensated liver disease, Non-AIDS malignancy, including basal and squamous cell skin cancers, AIDS, Bacterial pneumonia, Adverse events, Hospitalization, Quality of life (through December 2015), Health-care utilization and cost of care (through December 2015), HIV transmission risk behavior (through December 2015), HIV drug resistance, Pulmonary embolism or deep vein thrombosis, New-onset diabetes mellitus, Coronary artery disease requiring drug treatment, Congestive heart failure, Peripheral arterial disease, Change in estimated GFR and development of proteinuria, Blood pressure and blood lipids, ECG abnormalities (through December 2016), Use of blood pressure- or lipid-lowering treatment or aspirin, Fractures;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 attribu	—

Measure

Time frame

Main Objective: Based on two scientific hypotheses, both which take advantage of the randomized design of START and the extended follow-up through 2021, the primary objective is to determine whether the benefit of early ART as compared to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS, non-AIDS, or death from any cause is maintained, increased or reduced.;Secondary Objective: To compare early ART to deferred ART for the following secondary outcomes: All-cause mortality, ESRD (initiation of dialysis, renal transplantation), Decompensated liver disease, Non-AIDS malignancy, including basal and squamous cell skin cancers, AIDS, Bacterial pneumonia, Adverse events, Hospitalization, Quality of life (through December 2015), Health-care utilization and cost of care (through December 2015), HIV transmission risk behavior (through December 2015), HIV drug resistance, Pulmonary embolism or deep vein thrombosis, New-onset diabetes mellitus, Coronary artery disease requiring drug treatment, Congestive heart failure, Peripheral arterial disease, Change in estimated GFR and development of proteinuria, Blood pressure and blood lipids, ECG abnormalities (through December 2016), Use of blood pressure- or lipid-lowering treatment or aspirin, Fractures;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 attribu

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Secondary

Measure	Time frame
Secondary end point(s): Separate components of the composite outcome; all-cause mortality; all AIDS events (including esophageal candidiasis and chronic Herpes simplex); all non-AIDS-defining cancers (including basal and squamous cell skin cancers); bacterial pneumonia; pulmonary embolism; deep vein thrombosis; new-onset diabetes mellitus; coronary artery disease requiring drug treatment; congestive heart failure; peripheral vascular disease; fractures; and adverse events. In addition Quality of Life; health care utilization; health care cost; transmission risk behavior; drug resistance & markers of CVD. ;Timepoint(s) of evaluation of this end point: The endpoints will be assessed as part of the extended follow-up. All of these endpoints have been assessed since the beginning of the START trial in 2009; therefore, the two treatment strategies will be compared for the following three calendar periods: 1) from randomization to December 31, 2015; 2) from January 1, 2016 to December 31, 2021; and 3) cumulatively from randomization through 2021	—

Measure

Time frame

Secondary end point(s): Separate components of the composite outcome; all-cause mortality; all AIDS events (including esophageal candidiasis and chronic Herpes simplex); all non-AIDS-defining cancers (including basal and squamous cell skin cancers); bacterial pneumonia; pulmonary embolism; deep vein thrombosis; new-onset diabetes mellitus; coronary artery disease requiring drug treatment; congestive heart failure; peripheral vascular disease; fractures; and adverse events. In addition Quality of Life; health care utilization; health care cost; transmission risk behavior; drug resistance & markers of CVD. ;Timepoint(s) of evaluation of this end point: The endpoints will be assessed as part of the extended follow-up. All of these endpoints have been assessed since the beginning of the START trial in 2009; therefore, the two treatment strategies will be compared for the following three calendar periods: 1) from randomization to December 31, 2015; 2) from January 1, 2016 to December 31, 2021; and 3) cumulatively from randomization through 2021

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Countries

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

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 27, 2026