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Result Summary for COL40263

Result Summary

Protocol ID:	COL40263
Clinical Study ID:	COL40263
Official Title:	A Pilot, Open-Label, Multi-Center Study to Evaluate the Efficacy and Safety of a Once-Daily Regimen of Trizivir in Combination with Tenofovir Disoproxil Fumarate in Antiretroviral Therapy-Naïve Subjects with Viral Loads ?30,000 copies/mL
Phase:	phase 3
Study Indications or Diseases:	Infection, Human Immunodeficiency Virus
Generic Name:	abacavir/lamivudine/zidovudine
Trade/Product Name:	Ziagen,ZIAGENAVIR
Approved Drug Label:	http://www.gsk.com/products.html
Results Summary:	Click here to download result summary.
Citations:	Elion, R., et al. Selection of HIV Reverse Transcriptase (RT) Thymidine Analogue Mutations (TAMS) Rather than K65R is the Preferred Route of Resistance Seen in Patients with Virologic Failure on Once-Daily (QD) Trizivir (TZV) and Tenofovir (TDF). 45th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC December 16-19, 2005. Poster H-1068. Elion R., et al. COL40263: Resistance and Efficacy of Once-daily Trizivir and Tenofovir DF in Antiretroviral Naïve Subjects. 11th Conference on Retroviruses & Opportunistic Infections. San Francisco, CA, February 8-11, 2004. Oral M-138. DeJesus, E., et al. Week 24 Analysis of Once-Daily (QD) Trizivir (TZV) and Tenofovir DF (TDF) in Antiretroviral-naïve Subjects (COL40263). 44th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC, October 30 –November 2, 2004: Poster H-456. Lisa Ross, Randall Lanier, Edwin deJesus, Calvin Cohen, Robert R. Redfield, Joseph C. Gathe, Ricky K. Hsu, Linda Yau, D. Paulsen, Belinda Ha, and Richard Elion. Modulation of K65R Selection by Zidovudine Inclusion-Analysis of HIV Resistance Selection in Subjects with Virologic Failure Receiving Once-Daily Abacavir/ Lamivudine/ Zidovudine and Tenofovir DF (COL40263). [AIDS Res Hum Retroviruses]. 2009;25(7): Cohen, C., et al. Week 48 Analysis of Once-Daily (QD) Trizivir (TZV) and Tenofovir DF (TDF) in Antiretroviral Naïve Subjects (COL40263). 45th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC, December 16-19, 2005. Poster H-521. Ross L, et al. Low-abundance HIV species and their impact on mutational profiles in patients with virologic failure on once-daily abacavir/lamivudine/zidovudine and tenofovir. [J Antimicrob Chemother]. 2009; DeJesus E., et al. Week 24 Analysis of Once-Daily Trizivir (TZV) and Tenofovir DF (DF) in Antiretroviral Naive Subjects (COL40263). 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington DC, October 20-November 2, 2004. Poster 2950.