The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) proposes to build on nine years of experience conducting community-based clinical trials by expanding the clinical network to include 19 units in the United States and 3 international partners in Australia, Canada, and the United Kingdom. Support will be provided from the Statistical and Data Management Center at the University of Minnesota, an Operations Center at Social and Scientific Systems in Rockville, MD and Core CPCRA Laboratories. The reconfigured network has the capability of following a minimum of 5,000 study participants. The CPCRA will compare, in linked randomized trials, the long-term virologic, immunologic, and clinical effectiveness of various antiretroviral treatment strategies beginning with initial therapy through subsequent second-line and salvage regimens. The CPCRA will also study through randomized trials the clinical impact of immunomodulation as an adjunct to antiretroviral therapy; the optimal use of agents for prophylaxis of opportunistic infections in patients who have experienced CD4+ cell rebounds; and adherence interventions. The CPCRA will conduct nested substudies in the core antiretroviral trials, on targeted therapeutic questions such as the metabolic complications of HIV disease and treatment, and the emergence of HIV-1 resistance in different treatment groups. Pathogenesis questions such as the prognostic importance of virologic and immunologic markers will be addressed using stored specimens in the core antiretroviral trials. Standardized modular data collection forms are used across studies and will be used to describe patterns and determinants of clinical disease, drug resistance, adherence, drug toxicities, quality of life, co-infection with hepatitis, and use of HIV treatment. A strong leadership, advised by experienced and already functioning committees, will manage the CPCRA to ensure that studies are conducted in a timely way, high quality data is collected and resources are used efficiently.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AI046362-01
Application #
6021758
Study Section
Special Emphasis Panel (ZAI1-PSS-A (S1))
Program Officer
Batzold, Frederick
Project Start
2000-05-01
Project End
2005-03-31
Budget Start
2000-05-01
Budget End
2001-03-31
Support Year
1
Fiscal Year
2000
Total Cost
$3,026,291
Indirect Cost
Name
Social and Scientific Systems, Inc.
Department
Type
DUNS #
City
Silver Spring
State
MD
Country
United States
Zip Code
20910
Hatleberg, C I; Ryom, L; d'Arminio Monforte, A et al. (2018) Association between exposure to antiretroviral drugs and the incidence of hypertension in HIV-positive persons: the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. HIV Med 19:605-618
Ryom, Lene; Lundgren, Jens D; El-Sadr, Wafaa et al. (2018) Cardiovascular disease and use of contemporary protease inhibitors: the D:A:D international prospective multicohort study. Lancet HIV 5:e291-e300
Hart, Brian B; Nordell, Anna D; Okulicz, Jason F et al. (2018) Inflammation-Related Morbidity and Mortality Among HIV-Positive Adults: How Extensive Is It? J Acquir Immune Defic Syndr 77:1-7
Castillo-Mancilla, Jose R; Phillips, Andrew N; Neaton, James D et al. (2018) Association of Suboptimal Antiretroviral Therapy Adherence With Inflammation in Virologically Suppressed Individuals Enrolled in the SMART Study. Open Forum Infect Dis 5:ofx275
Murray, Daniel D; Suzuki, Kazuo; Law, Matthew et al. (2017) Circulating miR-122 and miR-200a as biomarkers for fatal liver disease in ART-treated, HIV-1-infected individuals. Sci Rep 7:10934
Achhra, A C; Mocroft, A; Reiss, P et al. (2016) Short-term weight gain after antiretroviral therapy initiation and subsequent risk of cardiovascular disease and diabetes: the D:A:D study. HIV Med 17:255-68
Ryom, Lene; Lundgren, Jens D; Ross, Mike et al. (2016) Renal Impairment and Cardiovascular Disease in HIV-Positive Individuals: The D:A:D Study. J Infect Dis 214:1212-20
Kovari, Helen; Sabin, Caroline A; Ledergerber, Bruno et al. (2016) Antiretroviral Drugs and Risk of Chronic Alanine Aminotransferase Elevation in Human Immunodeficiency Virus (HIV)-Monoinfected Persons: The Data Collection on Adverse Events of Anti-HIV Drugs Study. Open Forum Infect Dis 3:ofw009
Friis-Møller, Nina; Ryom, Lene; Smith, Colette et al. (2016) An updated prediction model of the global risk of cardiovascular disease in HIV-positive persons: The Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) study. Eur J Prev Cardiol 23:214-23
Larson, Gregg S; Carey, Cate; Grarup, Jesper et al. (2016) Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials 13:127-36

Showing the most recent 10 out of 135 publications