Abstract

This is a randomized, double-blind clinical trial involving subjects with prolonged prior experience with zdv/ddi or zdv/ddc combination therapies. Eligible subjects were participants in actg 175 who remained on their initially assigned combination therapy until the end of follow-up in actg 175 or were crossed over to one of the combination therapies (because of a 50% decline from baseline in cd4+ cell count or the development of major HIV-related disease) they must also have remained on that combination therapy for any intervening period between the end of data collection for actg 175 (Feb 28, 1995) and entry into this study. Subjects were randomized to one of three treatment arms; either to continue their zdv/ddi or zdv/ddc, or to add 3tc to their zdv/ddi or zdv/ddc or to switch to zdv/3tc. The study was partially blinded in that subjects took either ddi or ddi placebo, or ddc or ddc placebo, as well as 3tc or 3tc placebo. The primary outcome measure was change in HIV RNA copy number. The duration of study treatment was planned to be 48 weeks.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000051-37
Application #
6275371
Study Section
Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
37
Fiscal Year
1998
Total Cost
Indirect Cost

  Institution

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

  Publications

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
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

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