ACTG Research Agenda Specific Aims

The intent of this posting is to provide, in a transparent way, for new and recompeting clinical trial sites an overview of the proposed scientific program of the ACTG. The content is specifically designed to accommodate the request from investigators interested in submitting CTU/CRS applications in the area of Therapeutics.

Research Agenda Specific Aims

The AIDS Clinical Trials Group (ACTG) is focused on the conduct of clinical trials to inform strategies to end the HIV epidemic by improving treatment and reducing morbidity and mortality for people living with HIV. The network that began by setting the standards for antiretroviral treatment and opportunistic infection prevention and treatment has evolved to address the remaining challenges in HIV therapeutics. The ACTG is an open, dynamic, international, multi-disciplinary group of investigators poised to address the most significant questions in the treatment of HIV, HIV- related co-morbidities, tuberculosis and hepatitis B. We continue to engage new investigators, develop strategies to build scientific capacity globally and strengthen our alliances with other DAIDS networks and with outside groups in order to achieve our goals. The ACTG will design, conduct and publish high impact clinical trials to transform the science of therapeutic interventions in the areas of 1) antiretroviral free HIV remission, 2) novel interventions targeting HIV 3) tuberculosis, 4) HIV co-morbidities and hepatitis B cure guided by the following Specific Aims:

  1. Identify interventions to reduce HIV reservoirs and control HIV replication in the absence of ART
    The ACTG will advance the understanding of factors that contribute to the maintenance and decay of the HIV reservoir on contemporary ART and test interventions that will lead to control of HIV reactivation and replication in the absence of ART. To accomplish these goals, we propose a portfolio of activities, including innovative clinical studies, cutting-edge laboratory assessments, and partnerships with the Delaney Collaboratory investigators that will fill key knowledge gaps and identify therapies that will control HIV replication. With strong community involvement and access to well characterized populations of people living with HIV who were treated during both acute and chronic infection the network is poised to achieve these goals.
     
  2. Test novel and durable interventions targeting HIV infection
    The ACTG has a robust agenda to test novel interventions including broadly neutralizing antibodies, long acting antiretroviral agents and antivirals with new mechanisms of action to further transform the treatment of HIV infection. The Network will conduct early phase studies, evaluate proof of concept strategies and conduct comparative efficacy trials, when appropriate, to address unmet needs in HIV therapeutics in populations representative of the US and Global Epidemics. In collaboration with other funders we will evaluate behavioral, mental health or structural intervention to increase the durability of successful novel intervention.
     
  3. Improve the treatment and prevention of drug sensitive and drug resistant tuberculosis
    The ACTG aims to transform tuberculosis therapeutics by evaluating novel combinations of anti-tuberculous agents, treatment shortening regimens and strategies, including vaccines, for the treatment of active drug sensitive or multidrug resistant TB and for the prevention of active TB disease in those who have been exposed or successfully treated. The ACTG, along with effective outside collaborators, have established a global infrastructure to carry out these aims in people with or at risk for TB with or without HIV.
     
  4. Prevent or improve the treatment of HIV-related non-infectious co-morbidities and evaluate strategies to cure hepatitis B virus infection in people with and without HIV
    Non-infectious Co-morbidities
    The ACTG will evaluate targeted interventions to reduce the morbidity associated with these complications including cardiovascular, metabolic/obesity, neurologic and aging related co-morbidities.
    Hepatitis B Cure
    In partnership with industry collaborators we propose a focused scientific agenda to identify strategies for functional cure of hepatitis B virus infection in people with and without HIV. We will identify and define immunologic and virologic biomarkers associated with HBV clearance and immune control, leveraging blood and tissue specimens collected during clinical trials.