Accomplishments
ACTG TIMELINE
The ACTG has been pivotal in providing the data necessary for the approval of therapeutic agents, as well as the treatment and prevention strategies, for many opportunistic infections and malignancies.
- In 1986 the original AIDS Treatment and Evaluation Units were established by the National Institutes of Health.
- In 1987, the AIDS Clinical Trials Group (ACTG) was established by the National Institute of Allergy and Infectious Diseases
- In 1991 the ACTG split to create the Adult ACTG (AACTG) and the Pediatric ACTG (PACTG)
- In 1995 the AACTG restructured and created a true self-government structure, with self-evaluation of sites, priority setting of scientific research, discretionary spending. The PACTG became its own group and an AIDS Malignancy Consortium was established under the National Cancer Institute.
- In 1999 the AACTG applied for continued funding as an investigator led and run group
- In 2000 the AACTG began the planning and development of international research initiatives in the developing world
SCIENTIFIC ACCOMPLISHMENTS
Executive Summary of the Major Scientific, Administrative, and International Therapeutic Research Accomplishments of the AACTG for 2004
Previous Scientific Accomplishments
- Integral involvement in new antiretroviral drug development: AZT, ddC, ddI, d4T, nevirapine, delavirdine, indinavir, amprenavir, ritonavir
- Established standards for evaluation of combination antiretroviral therapy with: Nucleoside reverse transcriptase inhibitors
- Protease inhibitors
- Strategies for sequencing of regimens or enhancing their activity
- Evaluation of approaches to salvage therapy
- Evaluation of novel immune-based therapies
- Interferons, GM-CSF, G-CSF, thalidomide, IL-2, IL-12, CsA, prednisone, cytotoxic agents, therapeutic immunization
- Evaluation of pharmacokinetics of novel agents and important drug interactions
- Established standard of care for treatment and prevention of HIV-1 associated opportunistic complications:
- Pneumocystis carinii pneumonia
- CMV retinitis
- Cryptococcal meningitis
- Toxoplasmic encephalitis
- Hepatitis B and Hepatitis C
- Histoplasmosis
- Herpes virus infections
- Mycobacterium avium complex disease
- Tuberculosis
- Established standard of care for treatment of HIV-1 associated malignancies
- Evaluation of neurologic complications of HIV/AIDS - dementia, sensory neuropathy
ADMINISTRATIVE ACCOMPLISHMENTS
- Established an elite national clinical trials infrastructure
- Contributed to the establishment of expert HIV clinical care in the community
- Established a sophisticated distributed electronic data entry and laboratory data management system
- Established clinical trial site performance standards
- Refined investigator-initiated concept/protocol development process
- Standardized case report forms, clinical endpoint definitions, toxicity endpoint definitions
- Established an integrated Community Constituency Group and Community Advisory Boards
TRAINING AND EDUCATION
- Training and mentoring of junior investigators
- Training of study coordinators, research nurses, data managers, laboratory technologists
- Establishment and funding of a Minority AIDS Fellowship Training Program
- Mentoring for the Community Constituency Group and Community Advisory Boards, training and education for community activists
- Establishment of projects to enhance the recruitment and retention of women and other under-represented minority populations in clinical trials
OTHER ACCOMPLISHMENTS
- More than 1500 manuscripts published in major peer-reviewed journals; more than 120 since 2000 alone
- Establishment of state-of-the-art Virology, Immunology and Pharmacology support laboratory system performance standards
- Consensus and novel assay development and QA/QC programs with incorporation into clinical trials and clinical care
- Establishment of a central specimen repository
- Establishment of a central DNA repository
- Central metabolic laboratory system and central reading centers for CT and DEXA scans
- Improving clinical care, survival, and quality of life for persons with HIV/AIDS
- Developing approaches to clinical and translational research that are increasingly transforming clinical investigation directed at other illnesses