Abstract

ACTG 315 - A Pilot Study to Evaluate the Immunologic Consequences of a Highly Active Anitretroviral Therapy Regimen (HAARTR) Consisting of Ritonavir (ABT-538), Zidovudine (ADV), and Lamivudine (3TC) in Moderately Advanced HIV-1 Disease; This study explored whether administration of a highly active antiretroviral treatment regimen (HAARTR) consisting of ritonavir (ABT-538), zidovudine (ZDV), and lamivudine (3TC) in combination would restore delayed type hypersensitivity and lymphocyte proliferative responses in subjects with moderately advanced HIV-1 infection. The study also examined whether cells of the monocyte/macrophage lineage represent a reservoir of HIV-1 infection that continues low-level production of virus after initiation of antiretroviral therapy. This study was a 48-week, open-label pilot trial of a HAARTR consisting of ritonavir, zidovudine, and lamivudine. Forty-eight evaluable subjects with moderately advanced HIV-1 infection (CD4+ cell count between 100-300 cells/mm3) received the following open label treatment regimen for 48 weeks: Ritonavir 300mg BID for two days, then Ritonavir 400mg BID for two days, then Ritonavir 500 mg BID for two days, then, Ritonavir 600 mg BID for three days. On Study Day 10 and through Week 48, the treatment regimen consisted of: ritonavir 600 mg BID plus zidovudine 300 mg TID plus lamivudine 150mg BID. 48-week data has been analyzed.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000051-38
Application #
6114149
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
38
Fiscal Year
1999
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

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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