Abstract

Protocol M98-863 is a Phase III, randomized, double-blind, multi-center, multi-country study of at least 48 weeks duration comparing the administration of ABT-378/Ritonavir plus Stavudine and Lamivudine vs. Nelfinavir plus Stavudine and Lamivudine in antiretroviral-naive HIV-infected subjects. Approximately 660 subjects will be randomized in this study. Subjects will be equally randomized to one of two blinded treatment arms. Approximately 330 subjects will receive 400mg ABT-378/100mg Ritonavir BID plus Nelfinavir placebo TIP, and approximately 330 subjects will receive Nelfinavir 750mg TIP plus ABT-378/Ritonavir placebo BID. All subjects will receive open-label stavudine 30 or 40mg BID (based on weight) and lamivudine 150mg BID in combination with their assigned regimens. Antiretroviral-naive HIV-infected subjects who meet selection criteria will be enrolled. Measurements of vital signs, physical examinations, ECGs, routine clinical laboratory evaluations and determinations of antiviral and immunologic will be performed at intervals.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000750-28
Application #
6411802
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1976-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
28
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202

  Publications

Robinson-Cohen, Cassianne; Bartz, Traci M; Lai, Dongbing et al. (2018) Genetic Variants Associated with Circulating Fibroblast Growth Factor 23. J Am Soc Nephrol 29:2583-2592
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
Robarge, Jason D; Desta, Zereunesay; Nguyen, Anne T et al. (2017) Effects of exemestane and letrozole therapy on plasma concentrations of estrogens in a randomized trial of postmenopausal women with breast cancer. Breast Cancer Res Treat 161:453-461
Hertz, Daniel L; Speth, Kelly A; Kidwell, Kelley M et al. (2017) Variable aromatase inhibitor plasma concentrations do not correlate with circulating estrogen concentrations in post-menopausal breast cancer patients. Breast Cancer Res Treat 165:659-668
Patel, Yash R; Kirkman, M Sue; Considine, Robert V et al. (2017) Retinopathy predicts progression of fasting plasma glucose: An Early Diabetes Intervention Program (EDIP) analysis. J Diabetes Complications 31:605-610
Robarge, Jason D; Metzger, Ingrid F; Lu, Jessica et al. (2017) Population Pharmacokinetic Modeling To Estimate the Contributions of Genetic and Nongenetic Factors to Efavirenz Disposition. Antimicrob Agents Chemother 61:
Hertz, D L; Kidwell, K M; Seewald, N J et al. (2017) Polymorphisms in drug-metabolizing enzymes and steady-state exemestane concentration in postmenopausal patients with breast cancer. Pharmacogenomics J 17:521-527
Kadakia, Kunal C; Kidwell, Kelley M; Seewald, Nicholas J et al. (2017) Prospective assessment of patient-reported outcomes and estradiol and drug concentrations in patients experiencing toxicity from adjuvant aromatase inhibitors. Breast Cancer Res Treat 164:411-419
Criado, Kristen K; Sharp, William G; McCracken, Courtney E et al. (2017) Overweight and obese status in children with autism spectrum disorder and disruptive behavior. Autism :1362361316683888

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