Core - Pharmacology Laboratory

Roboz, John

Abstract

The broad, long-range objective of the Pharmacology Core Laboratory is to provide analytical pharmacology support for those clinical protocols which mandate drug testing for subsequent pharmacokinetic studies. There will be four specific aims: (a) Perform the determination of drug and, if indicated, selected metabolite levels in serum (plasma, or other body fluid) samples from AIDS or HIV positive patients participating in protocols which mandate such measurements; (b) Depending upon protocol requirements, use the results to carry our pharmacokinetic studies locally, or submit the results to an inter-institutional (network) central organization for comparative pharmacokinetic studies; (c) Adopt and/or modify existing analytical methodologies or develop new analytical methodologies to assure that the first specific aim is accomplished by utilizing the most advanced available analytical technology commensurate with the pharmacokinetic goals of the particular clinical protocol; (d) Utilize existing and, if needed, develop new, local quality assurance programs and also actively participate in inter-institutional (network) quality assurance programs for all drugs measured. Providing pharmacokinetic data will be of immediate and direct benefit to patients on ACTH protocols because they will permit adjustments of doses and regimen to increase efficacy and reduce toxicity.

Funding Agency

• Agency: National Institute of Health (NIH)
• Institute: National Institute of Allergy and Infectious Diseases (NIAID)
• Type: Research Project--Cooperative Agreements (U01)
• Project #: 2U01AI027667-07
• Application #: 3791344
• Support Year: 7
• Fiscal Year: 1992

Institution

• Name: Mount Sinai School of Medicine
• City: New York
• State: NY
• Country: United States
• Zip Code: 10029

Publications

Nasti, Tahseen H; Cochran, J Barry; Tsuruta, Yuko et al. (2016) A murine model for the development of melanocytic nevi and their progression to melanoma. Mol Carcinog 55:646-58

Zhao, Yu; Navia, Bradford A; Marra, Christina M et al. (2010) Memantine for AIDS dementia complex: open-label report of ACTG 301. HIV Clin Trials 11:59-67

Smith, Patrick F; Robbins, Gregory K; Shafer, Robert W et al. (2005) Pharmacokinetics of nelfinavir and efavirenz in antiretroviral-naive, human immunodeficiency virus-infected subjects when administered alone or in combination with nucleoside analog reverse transcriptase inhibitors. Antimicrob Agents Chemother 49:3558-61

Gilpin, Adele M Kaplan; Holbrook, Janet T; Jabs, Douglas A et al. (2003) Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial. Control Clin Trials 24:92-8

Holbrook, Janet T; Jabs, Douglas A; Weinberg, David V et al. (2003) Visual loss in patients with cytomegalovirus retinitis and acquired immunodeficiency syndrome before widespread availability of highly active antiretroviral therapy. Arch Ophthalmol 121:99-107

Jabs, Douglas A; Gilpin, Adele M Kaplan; Min, Yuan-I et al. (2002) HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial. AIDS 16:877-87

Martin, B K; Kaplan Gilpin, A M; Jabs, D A et al. (2001) Reliability, validity, and responsiveness of general and disease-specific quality of life measures in a clinical trial for cytomegalovirus retinitis. J Clin Epidemiol 54:376-86

Holbrook, J T; Meinert, C L; Jabs, D A et al. (2001) Patient notification and follow-up after suspension of treatment protocols. experience from four clinical trials of treatments for AIDS-related CMV retinitis. Control Clin Trials 22:62-8

Holbrook, J T; Meinert, C L; Van Natta, M L et al. (2001) Photographic measures of cytomegalovirus retinitis as surrogates for visual outcomes in treated patients. Arch Ophthalmol 119:554-63

Perlman, D C; El-Helou, P; Salomon, N (1999) Tuberculosis in patients with human immunodeficiency virus infection. Semin Respir Infect 14:344-52