Abstract

This is a four-arm, randomzied, partially-blind, multicenter, Phase II study of nucleoside analogues given alone or in combination to subjects with CD4+ cell counts between 300-600/mm3 and greater that 24 weeks of ZDV experience. The four treatment arms are 1) d4T alone, 2) ddI alone, 3) ZDV and ddI in combination, 4) ZDV and d4T in combination. The administration of d4T and ddI will be open-label. The study is double- blind with respect to ZDV treatment. The duration of the study is 48 weeks after the enrollment of the last subject. A 12 week blinded study extension wil be offered to all subjects still on blinded therapy upon the conclusion of the original 48 weeks after the last subject is enrolled.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000750-26
Application #
6278968
Study Section
Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
26
Fiscal Year
1998
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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