The primary objective of the study is to assess the safety, tolerability, and antiviral activity of ABT-378/ritonavir when administered orally in a group of approximately eight antiretroviral naive HIV-infected patients. There are 3 secondary objectives: 1) To determine the steady-state pharmacokinetic profile of ABT-378/ritonavir in antiretroviral naive HIV- infected patients; 2) to characterize the HIV RNA decay profiles of ABT-378/ritonavir in antiretroviral naive HIVinfected patients; and 3) to assess the relationship between ABT-378/fitonavir phamacokinetics and HIV RNA decay profiles in antiretroviral naive HIV-infected patients. In this protocol, patients are required to come to the GCRC for directly observed dosing of ABT378/ritonavir for the morning dose only during the first two weeks of therapy. EKGs and vital signs are performed on days 1, 5,9, and 14. Zero-hour PK sampling is done on days 1,4,7, 1 0, and 14. Blood for other laboratory evaluations (CBC, chemistry, flow cytometry, HIV-I RNA, etc.) is drawn at screening and on study days - 1, 4,5,7, 1 0, and 14. Patients are monitored for adverse events by the study coordinator on a daily basis during the first 14 days of the study, and at regularly scheduled visits thereafter. 12-hour pharmacokinetic studies are done on the CRU at week 3, week 6, and at 6 months. Two nucleoside reverse transcriptase inhibitors, stavudine and lamivudine, are added to the treatment regimen on day 22. Patients are seen for zero-hour PK sampling and routine lab work at week 4, 6, 8, 10, 12, 16, 20, 24, 36, 48, and 52. Physical examinations are performed at day -1, day 28, week 8, 12, 16, 20, 24,36, 48, and 52.
| 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 |
| Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247 |
| James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4 |
| Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628 |
| Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417 |
| Ahmed, Zuhayer; Prasad, Indrajit; Rahman, Hafizur et al. (2016) A Male with Extreme Subcutaneous Insulin Resistance: A Case Report. Rom J Diabetes Nutr Metab Dis 23:209-213 |
| Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17 |
| Barroso, Julie; Leserman, Jane; Harmon, James L et al. (2015) Fatigue in HIV-Infected People: A Three-Year Observational Study. J Pain Symptom Manage 50:69-79 |
| Stafford-Smith, Mark; Li, Yi-Ju; Mathew, Joseph P et al. (2015) Genome-wide association study of acute kidney injury after coronary bypass graft surgery identifies susceptibility loci. Kidney Int 88:823-32 |
Showing the most recent 10 out of 128 publications
