# Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)

> **NIH NIH UM1** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2020 · $14,994,115

## Abstract

DESCRIPTION (provided by applicant): Great strides have been made in the treatment of human immunodeficiency virus (HIV) and the opportunistic infections (01) associated with acquired immune deficiency syndrome (AIDS) over the last 30 years, resulting in substantial reductions in AIDS associated morbidity and mortality throughout the world. The AIDS Clinical Trials Group (ACTG) has been at the forefront of these efforts for more than 25 years. Clinical trials and laboratory studies conducted by the ACTG have produced major insights that form the cornerstones of current guidelines and standards of clinical management of HIV-1 infection and its co-morbidities and complications. Despite this impressive progress, substantial challenges remain in key aspects of HIV therapeutics. These include: strategies for eradicating HIV or achieving functional cure; diagnosis, treatment and prevention of tuberculosis, including multidrug-resistant (MDR) TB in co-infected and mono-infected patients; developing more effective and better tolerated regimens for the treatment of viral hepatitis in co-infected and monoinfected patients; reducing the persistent immune activation that accompanies treated chronic HIV infection and preventing the associated co-morbidities; developing novel interventions targeting HIV; and improving the diagnosis, treatment and prevention of HlV-associated malignancies. The ACTG proposes a comprehensive research agenda that draws on an international consortium of leading clinical and laboratory HIV investigators in collaboration with a world-class Statistics and Data Management Center to design and conduct innovative interventional clinical trials that will significantly reduce the global burden of diseae due to HIV, TB and hepatitis. Specific aims of the ACTG Network Leadership Group (LG) include:   
   
1. The ACTG Leadership and Operations Center (LOC). A newly restructured LOC is proposed to provide scientific leadership and fiscal and organizational management of the ACTG. The ACTG Executive Committee (AEC) will serve as the overarching governing body of the network. Transformative Science Groups will oversee the development and execution of the ACTG research agenda, which will be coordinated and prioritized by the Scientific Agenda Steering Committee (SASC). Protocol development, implementation, training and network evaluation will be facilitated by the Network Coordinating Center at Social & Scientific Systems, Inc. The LOC financial management group at Brigham and Women's Hospital (BWH) will oversee resource management and protocol fund distribution at the direction of the AEC. The LOC will assure the engagement of Community in all aspects of the ACTG, and will coordinate communication between all three components of the network.   
   
2. The ACTG Laboratory Center (LC). The ACTG LC will comprise Specialty Laboratories in virology,   
immunology, pharmacology, mycobacteriology and genomics equipped to perform protocol-specified test...

## Key facts

- **NIH application ID:** 9828046
- **Project number:** 5UM1AI068634-14
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** Michael David Hughes
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $14,994,115
- **Award type:** 5
- **Project period:** 2006-06-29 → 2020-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9828046

## Citation

> US National Institutes of Health, RePORTER application 9828046, Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG) (5UM1AI068634-14). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9828046. Licensed CC0.

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