Trial · NCT00867048

Strategic Timing of Antiretroviral Treatment

NCT00867048, Phase 4, Completed, University of Minnesota; results first posted 2023-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Strategic Timing of Antiretroviral Treatment. Trials, record NCT00867048. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00867048

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Strategic Timing of Antiretroviral Treatment
NCT number: NCT00867048
Status: Completed
Phases: Phase 4
Enrollment: 4,688 participants, actual
Lead sponsor: University of Minnesota
Conditions: HIV Infection
Interventions: All licensed antiretroviral medications
First posted: 2009-03-23
Last updated: 2024-03-04
Other registries' IDs: eudract:2008-006439-12
Results first posted: 2023-12-20

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality	full follow-up, 9.3 years
Secondary	AIDs or AIDs Related Death	full follow-up, 9.3 years	participant count
Secondary	Specific Non-AIDS Diagnoses	full follow-up, 9.3 years
Secondary	Death, All-cause Mortality	full follow-up, 9.3 years	Count of participants
Secondary	Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health	4.5 years	Mean change from baseline of the VAS. This was a single data item where participants self-reported their perceived current state of health on a scale of 0-100 (0=worst possible and 100=best possible).
Secondary	Transmission Risk Behavior Outcome 1	12 months	Proportion of participants identifying as men who have sex with men (MSM) engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.
Secondary	Change in Neurocognitive Function (in a Subset of Participants)	4.5 years	Mean change from baseline of the QNPZ-8 score. In the Neurology substudy of START, participants were administered a neuropsychological test battery of 8 tests (grooved peg board, finger tapping, Color Trails 1 and 2, Semantic Verbal Fluency, WAIS III Digit Symbol, HVLT-R Learning, HVLT-R Delayed Recall). Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Z-scores \> 0 indicate improvement over baseline levels. The quantitative neuropsychological performance z-score (QNPZ-8) was the mean of the z-scores across the the 8 tests. Analyses were by intention-to-treat principles.
Secondary	Large Artery Elasticity (in a Subset of Participants)	4.5 years	Mean change from baseline in large arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.
Secondary	Rate of Lung Function Decline (in a Subset of Participants) Among	4.5 years	Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.
Secondary	Changes in Bone Mineral Density (in a Subset of Participants) Measure 1	4.5 years	Mean percent change from baseline in bone mineral density at the spine. In the bone mineral density (BMD) substudy of START, participants underwent dual-enery x-ray absorptionmetry (DXA) to measure BMD at the spine and hip at baseline and annually. Analyses were by intention-to-treat principles.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality	full follow-up, 9.3 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	AIDs or AIDs Related Death	full follow-up, 9.3 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Specific Non-AIDS Diagnoses	full follow-up, 9.3 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Death, All-cause Mortality	full follow-up, 9.3 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health	4.5 years	units on a scale	MEAN
SECONDARY	Transmission Risk Behavior Outcome 1	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Neurocognitive Function (in a Subset of Participants)	4.5 years	units on a scale	MEAN
SECONDARY	Large Artery Elasticity (in a Subset of Participants)	4.5 years	mL/mmHg x 10	MEAN
SECONDARY	Rate of Lung Function Decline (in a Subset of Participants) Among	4.5 years	mL/yr	MEAN
SECONDARY	Changes in Bone Mineral Density (in a Subset of Participants) Measure 1	4.5 years	percent	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality	Early ART	133		Participants
Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality	Deferred ART	215		Participants
AIDs or AIDs Related Death	Early ART	31		Participants
AIDs or AIDs Related Death	Deferred ART	83		Participants
Specific Non-AIDS Diagnoses	Early ART	107		Participants
Specific Non-AIDS Diagnoses	Deferred ART	137		Participants
Death, All-cause Mortality	Early ART	66		Participants
Death, All-cause Mortality	Deferred ART	85		Participants
Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health	Early ART	1.8	Standard Deviation 8.6	units on a scale
Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health	Deferred ART	0.22	Standard Deviation 8.7	units on a scale

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Early ART	2,326
Overall Study	STARTED	Deferred ART	2,362
Overall Study	COMPLETED	Early ART	2,325
Overall Study	COMPLETED	Deferred ART	2,359
Overall Study	NOT COMPLETED	Early ART	1
Overall Study	NOT COMPLETED	Deferred ART	3

Source ClinicalTrials.gov

Adverse events1,142

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Anaemia	Blood and lymphatic system disorders	Early ART	5	2,325	6
serious	Anaemia	Blood and lymphatic system disorders	Deferred ART	7	2,359	7
serious	Febrile bone marrow aplasia	Blood and lymphatic system disorders	Early ART	0	2,325	0
serious	Febrile bone marrow aplasia	Blood and lymphatic system disorders	Deferred ART	1	2,359	1
serious	Febrile neutropenia	Blood and lymphatic system disorders	Early ART	1	2,325	1
serious	Febrile neutropenia	Blood and lymphatic system disorders	Deferred ART	1	2,359	3
serious	Lymphadenopathy	Blood and lymphatic system disorders	Early ART	1	2,325	1
serious	Lymphadenopathy	Blood and lymphatic system disorders	Deferred ART	1	2,359	1
serious	Neutropenia	Blood and lymphatic system disorders	Early ART	0	2,325	0
serious	Neutropenia	Blood and lymphatic system disorders	Deferred ART	1	2,359	1

1 to 10 of 1,142Source ClinicalTrials.gov

See all 1,142 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Early ART	66	2,325
Total, all-cause mortality	Deferred ART	85	2,359
Total, other adverse events	Early ART	0	0
Total, other adverse events	Deferred ART	0	0
Total, serious adverse events	Early ART	428	2,325
Total, serious adverse events	Deferred ART	500	2,359

Source ClinicalTrials.gov

Papers34

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21951596	DERIVED	PubMed
22547421	BACKGROUND	PubMed
25711317	DERIVED	PubMed
25711318	DERIVED	PubMed
25711319	DERIVED	PubMed
25711320	DERIVED	PubMed
25711321	DERIVED	PubMed
25711322	DERIVED	PubMed
25711323	DERIVED	PubMed
25711324	DERIVED	PubMed

1 to 10 of 34

See all 34 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AI068641	International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)	NEATON, JAMES DENNIS	UNIVERSITY OF MINNESOTA	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2006 to 2010

Source NIH RePORTER

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Early ART vs Deferred ART: AIDs or AIDs Related Death	Trial comparisons
Early ART vs Deferred ART: Transmission Risk Behavior Outcome 1	Trial comparisons
Early ART vs Deferred ART: Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality	Trial comparisons
Early ART vs Deferred ART: Transmission Risk Behavior Outcome 2	Trial comparisons
Early ART vs Deferred ART: Death, All-cause Mortality	Trial comparisons
Early ART vs Deferred ART: deaths from any cause	Trial comparisons
Early ART vs Deferred ART: Specific Non-AIDS Diagnoses	Trial comparisons
Early ART vs Deferred ART: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Verbal Fluency	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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