# Extended follow-up of randomized participants in the INSIGHT START trial

> **NIH NIH U01** · UNIVERSITY OF MINNESOTA · 2020 · $4,518,021

## Abstract

Project Summary
The Strategic Timing of Antiretroviral Treatment (START) is an international randomized trial
designed to determine whether initiation of ART at CD4+ counts > 500 cells/mm3 (immediate
or early ART) is superior in terms of morbidity and mortality to deferral of ART until the CD4+
declines to 350 cells/mm3 (deferred ART). On May 15, 2015 after an average of 3 years of
follow-up, the independent Data and Safety Monitoring Board (DSMB) for START determined
that the study primary question had been answered. Over an average follow-up of 3 years,
immediate use of ART provided significant benefit over deferred ART for the primary endpoint
(a composite of AIDS and non-AIDS events) of START (rates were 0.60 and 1.38 per 100
person years for the immediate and deferred ART groups. The DSMB recommended that
results be immediately disseminated, that participants in the deferred ART group be offered
ART, and recognizing the relatively short follow-up, that follow-up continue. With this proposal,
investigators in the International Network for Strategic Initiatives in Global HIV Trials
(INSIGHT) will continue follow-up of the 4,684 HIV-positive participants enrolled in START
through December 2021, and carry out final data analyses aimed at determining whether the
risk of major morbidity and mortality associated with delayed initiation is eliminated once ART
is initiated and HIV RNA levels are suppressed or whether it persists. No prior randomized trial
has addressed this question. Multiple papers will summarize the long-term follow-up findings
and results will also be presented at scientific conferences.

## Key facts

- **NIH application ID:** 9931133
- **Project number:** 5U01AI136780-02
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** James Dennis Neaton
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $4,518,021
- **Award type:** 5
- **Project period:** 2019-05-17 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9931133

## Citation

> US National Institutes of Health, RePORTER application 9931133, Extended follow-up of randomized participants in the INSIGHT START trial (5U01AI136780-02). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/9931133. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*