Abstract

This contract is one of a number of awards solicited under a single RFP designed to put in place a number of clinical research facilities that would have the capability of performing Phase 1 and Phase 2 clinical studies in patients infected with HIV (Human Immunodeficiency Virus). These studies are necessary for the NIAID to identify a safe and possibly efficacious treatment regimen for this infection. The studies will provide information, in addition, on the pharmacokinetics of the drugs evaluated and their metabolites. The contractor will be responsible for assessing the patient's response therapy using performance status, drug response, pharmacokinetic assays, and toxicity criteria designated in advance. The contractor will be responsible for performing viral isolation assays from a variety of clinical samples, for evaluating immunologic status prior to, during, and after therapy, and for performing in-depth pharmacokinetic analysis on a subset of patients treated. Clinical status of the patients will be regularly monitored. Data will be submitted by remote entry to a centralized coordinating center. Investigators will meet regularly with the AIDS Drug Selection Committee to discuss current and future studies and resolve technical issues through focused workshops.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research and Development Contracts (N01)
Project #
N01AI072624-000
Application #
3595948
Study Section
Project Start
1987-01-02
Project End
1991-06-29
Budget Start
1987-01-02
Budget End
1988-01-01
Support Year
Fiscal Year
1987
Total Cost
Indirect Cost

  Institution

Name
Duke University
Department
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705