An Inventory Of Federally Sponsored HIV And HIV-Relevant Databases. Database: Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) Observational Data Base (ODB)

07/01/2000

NIAID

Purpose Of The Database And Study Design: CPCRA was established in 1989 to broaden the scope of the HIV research effort of NIAID to include clinical trials conducted in community-based settings. The main goal of the CPCRA is to obtain evidence to properly inform health care providers and people living with HIV about the most appropriate use of available HIV therapies in diverse populations across the spectrum of HIV disease.

The CPCRA is a network of community-based health care providers who have integrated scientific research into primary care. It now includes 15 research units, a statistical center, and an operations center. Research units are based in a variety of primary care settings, including private practices, community clinics, university outpatient departments, and VA hospitals. Located in 14 cities across the US, these 15 units and their patient base represent diverse geographic, racial, and risk groups. The CPCRA offers access to a large number of patients whose demographic characteristics reflect those of the evolving HIV epidemic. The CPCRA has established clinician/patient relationships that enhance patient retention and compliance in clinical studies and allow for long-term follow-up.

The scientific agenda for the CPCRA focuses on answering key clinical management questions that face providers and patients every day. The agenda is constructed around a core of antiretroviral treatment trials. CPCRA trials are designed with nested substudies aimed at understanding the pathogenesis of HIV infection and the public health implications of its treatment. These trials are complemented with substudies and other trials focused on issues of current interest. Antiretroviral and immunomodulatory research focuses on studies designed to determine the durability of virologic suppression of initial drug regimens and evaluate the virologic changes caused by second- and third-line regimens, as well as analyze the clinical consequences of the entire treatment sequence. The CPCRA plans to investigate the clinical outcome of patients with early HIV infection who receive an immunomodulator, as well as investigate various treatment combinations and sequences in this patient population.

The CPCRA studies how the spectrum of complication of HIV disease is changing and whether OI prophylaxis and treatment strategies should be modified. In addition, the CPCRA is interested in nutritional and metabolic disregulation and their effects on the pathogenesis, treatment, and clinical course of HIV disease.

The ODB is a data file of baseline and disease incidence information on 5,104 HIV positive patients enrolled between September 1990 and November 1992. Baseline variables include demographic characteristics, treatments, CD4 count, and HIV risk factors. Follow-up data through July 1, 1994 are included for 44 different incident opportunistic events and death.

Process To Access The Database And Contact Person: For additional information contact: Jonathan Kagan, MD, Therapeutics Research Program, DAIDS, NIAID, (301) 402-0131. Information regarding the CPCRA studies listed below may be obtained from the NTIS.

Study # Title NTIS Reference #
001 A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV positive Individuals with Serologic Evidence. PB95-503405GEI (diskette and protocol)

PB95-19151 (documentation only)

002 A Prospective, Randomized Open-Label, Comparative Trial of Dideoxyinosine versus Dideoxycytidine in HIV positive Patients Who Are Intolerant of or Who Failed Zidovudine Therapy. PB95-503413GEI (diskette and protocol)

PB95-191169 (documentation only)

CPCRA Observational Data Base   PB96-500897
CPCRA Cross-Study Data Base   PB96-500889

Selected Citations:

Please refer to the CPCRA webpage for a complete and up-to-date listing of abstracts and publications: http://www.cpcra.org/publications/.

Burns DN, Hillman D, Neaton JD, Sherer R, Mitchell T, Capps L, Vallier WG, Thurnherr MD, Gordin FM. Cigarette smoking, bacterial pneumonia and other clinical outcomes in HIV-1 Infection. JAIDS, 13(4): 374-383, 1996.

Torres RA, Neaton JD, Wentworth D, Barr MR, Abrams D, Sherer R, Ward T, Sampson J. Acyclovir and survival in an observational cohort enrolled by the Community Programs for Clinical Research on AIDS (CPCRA). Clin Infect Dis, 26: 85-90, 1996.

Melnick SL, Sherer R, Louis TA, Hillman D, Rodriguez EM, Lackman, Capps L. Survival and disease progression according to gender of patients with HIV infection. JAMA. 272(24): 1915-1921, 1996.