This is a prospective, multicenter, observational study of HIV-infected subjects who are CMV-seropositive and who have not had clinical symptoms of CMV disease at study entry. Subjects will be followed for three years or until the diagnosis of CMV end-organ disease, or death, whichever comes first. Clinical evaluations will be performed at baseline and every 8 weeks. Blood samples for virologic studies will be obtained every 16 weeks. Blood samples will also be stored every 16 weeks for future immunologic studies. Routine clinical evaluations will be performed prior to enrollment and every 8 weeks for the duration of the study. Ophthalmologic evaluations will be performed at baseline and at 24-week intervals, as well as whenever symptoms indicate a need for a diagnostic evaluation for CMV retinitis. CD4/CD8 counts will be monitored and plasma and polymorphonuclear blood leukocytes will be stored for quantitative HIV RNA and CMV DNA studies at baseline, 16-week intervals, and whenever CMV end-organ disease is diagnosed. Evaluations for non-ocular disease will be performed when clinically indicated and according to predetermined guidelines. Co-enrollment will be permitted in other ACTG studies. This study aims to analyze in detail the relationships between HIV load, CMV load, and CMV end-organ disease in patients with AIDS who are at risk for developing this complication. In addition, the study will describe the natural history of CMV infection in patients receiving a variety of antiretroviral therapies (including HAART), or no anti-HIV therapy at all.

Project Start
1999-12-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
28
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
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

Showing the most recent 10 out of 767 publications