Abstract

ACTG 384 - Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor with Dual Nucleosides in Initial Therapy of HIV Infection. The primary hypotheses being tested in this protocol include the following: 1) the initial use of two nucleoside reverse transcriptase inhibitor, (NRTIs) + nelfinavir (NFV) followed (for those who fail) by the use of two different NRTIs + EFZ, is superior to the initial use of two NRTIs + EFZ followed (for those who fail) by two different NRTIs + NFV; 2) the initial use of two NRTIs + NFV + EFZ is superior to either of the two consecutive 3 drug regimens outlined in hypothesis 1 above; and 3) the use of lamivudine/zidovudine (3TC/ZDV) followed by the use of didanosine (ddl) + Stavudine (d4T)(for those who fail the initial ddl/d4T regimen) when these two NRTI combinations are taken with NFV or EFZ. This will be a multicenter trial with 800 subjects. Subjects will be enrolled over approximately 1 year. All subjects will receive randomized study treatment until study closure or for a maximum study duration of approximately 3 years. Treatment progresses through three treatment regimens.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000051-39
Application #
6304245
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
39
Fiscal Year
2000
Total Cost
$32,212
Indirect Cost

  Institution

Name
University of Colorado Denver
Department
Type
DUNS #
065391526
City
Aurora
State
CO
Country
United States
Zip Code
80045

  Publications

Millstein, Richard J; Pyle, Laura L; Bergman, Bryan C et al. (2018) Sex-specific differences in insulin resistance in type 1 diabetes: The CACTI cohort. J Diabetes Complications 32:418-423
Martin, Maureen P; Naranbhai, Vivek; Shea, Patrick R et al. (2018) Killer cell immunoglobulin-like receptor 3DL1 variation modifies HLA-B*57 protection against HIV-1. J Clin Invest 128:1903-1912
Nowak, Kristen L; You, Zhiying; Gitomer, Berenice et al. (2018) Overweight and Obesity Are Predictors of Progression in Early Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 29:571-578
Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187
Venuto, Charles S; Lim, Jihoon; Messing, Susan et al. (2018) Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s. Antivir Ther 23:345-351
Li, Binglan; Verma, Shefali S; Veturi, Yogasudha C et al. (2018) Evaluation of PrediXcan for prioritizing GWAS associations and predicting gene expression. Pac Symp Biocomput 23:448-459
Hayden, Kathleen M; Baker, Laura D; Bray, George et al. (2018) Long-term impact of intensive lifestyle intervention on cognitive function assessed with the National Institutes of Health Toolbox: The Look AHEAD study. Alzheimers Dement (Amst) 10:41-48
Shah, V N; Sippl, R; Joshee, P et al. (2018) Trabecular bone quality is lower in adults with type 1 diabetes and is negatively associated with insulin resistance. Osteoporos Int 29:733-739
Jensen, Thomas; Bjornstad, Petter; Johnson, Richard J et al. (2018) Copeptin and Estimated Insulin Sensitivity in Adults With and Without Type 1 Diabetes: The CACTI Study. Can J Diabetes :
Dad, Taimur; Abebe, Kaleab Z; Bae, K Ty et al. (2018) Longitudinal Assessment of Left Ventricular Mass in Autosomal Dominant Polycystic Kidney Disease. Kidney Int Rep 3:619-624

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