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Tenofovir Disoproxil Fumarate in Nucleoside-Resistant HIV-1 Infection: A Randomized Trial

Kathleen Squires, MD; Anton L. Pozniak, MD; Gerald Pierone Jr., MD; Corklin R. Steinhart, MD, PhD; Daniel Berger, MD; Nicholaos C. Bellos, MD; Stephen L. Becker, MD; Michael Wulfsohn, MD, PhD; Michael D. Miller, PhD; John J. Toole, MD, PhD; Dion F. Coakley, PharmD; Andrew Cheng, MD, PhD, Study 907 Team*
[+] Article and Author Information

From Keck School of Medicine, University of Southern California, Los Angeles, California; Chelsea and Westminster Hospital, London, United Kingdom; Treasure Coast Infectious Disease, Vero Beach, and Florida/Caribbean AIDS Education Training Center, Miami, Florida; Northstar Medical Center, Chicago, Illinois; Southwest Infectious Disease, Dallas, Texas; and Pacific Horizon Medical Group, San Francisco, and Gilead Sciences, Foster City, California.


Presented in part at the 6th International Congress on AIDS in Asia and the Pacific, Melbourne, Australia, 5–10 October 2001; the 8th European Conference on Clinical Aspects and Treatment of HIV Infection, European AIDS Clinical Society, Athens, Greece, 28–31 October 2001; the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy, American Society for Microbiology, Chicago, Illinois, 16–19 December 2001; the 9th Conference on Retroviruses and Opportunistic Infections, Foundation for Retrovirology and Human Health, Seattle, Washington, 24–28 February 2002; and the 14th International AIDS Conference, International AIDS Society, Barcelona, Spain, 7–12 July 2002.

Acknowledgments: The authors gratefully acknowledge the contributions of all the study site personnel and patients who participated in this study.

Grant Support: By Gilead Sciences, Foster City, California.

Potential Financial Conflicts of Interest:Employment: M. Wulfsohn (Gilead Sciences), M.D. Miller (Gilead Sciences), J.J. Toole (Gilead Sciences), D.F. Coakley (Gilead Sciences), A. Cheng (Gilead Sciences); Consultancies: K. Squires (Gilead Sciences), G. Pierone, D. Berger (Gilead Sciences), S.L. Becker; Honoraria: K. Squires (Gilead Sciences), G. Pierone, D. Berger (Gilead Sciences), S.L. Becker; Stock ownership: D. Berger (Gilead Sciences), M. Wulfsohn (Gilead Sciences), M.D. Miller (Gilead Sciences), J.J. Toole, D.F. Coakley (Gilead Sciences), A. Cheng (Gilead Sciences); Grants received: K. Squires, G. Pierone, S.L. Becker; Grants pending: K. Squires; Other: A.L. Pozniak.

Requests for Single Reprints: Andrew Cheng, MD, PhD, 333 Lakeside Drive, Foster City, CA 94404.

Current Author Addresses: Dr. Squires: LAC + USC Medical Center, 1300 North Mission Road, Room 352, Los Angeles, CA 90033.

Dr. Pozniak: St. Stephen's Centre, Chelsea and Westminster Hospital, 369 Fulham Road, London SW109TH, United Kingdom.

Dr. Pierone: 3755 7th Terrace, Suite 302A, Vero Beach, FL 32960.

Dr. Steinhart: Mercy Professional Building, 3661 South Miami Avenue, Suite 806, Miami, FL 33133-4231.

Dr. Berger: 2835 North Sheffield Avenue, Suite 104, Chicago, IL 60657.

Dr. Bellos: 3801 Gaston Avenue, Suite 300, Dallas, TX 75246.

Dr. Becker: 2351 Clay Street, Suite 512, San Francisco, CA 94115.

Drs. Wulfsohn, Miller, Toole, Coakley, and Cheng: 333 Lakeside Drive, Foster City, CA 94404.

Author Contributions: Conception and design: M. Wulfsohn, M.D. Miller.

Analysis and interpretation of the data: K. Squires, M. Wulfsohn, M.D. Miller, J.J. Toole, D.F. Coakley, A. Cheng.

Drafting of the article: K. Squires, A.L. Pozniak, G. Pierone, M.D. Miller, D.F. Coakley, A. Cheng.

Critical revision of the article for important intellectual content: K. Squires, A.L. Pozniak, G. Pierone, C.R. Steinhart, D. Berger, N.C. Bellos, S.L. Becker, M. Wulfsohn, M.D. Miller, J.J. Toole, D.F. Coakley, A. Cheng.

Final approval of the article: K. Squires, A.L. Pozniak, G. Pierone, C.R. Steinhart, D. Berger, N.C. Bellos, S.L. Becker, M. Wulfsohn, M.D. Miller, J.J. Toole, D.F. Coakley, A. Cheng.

Provision of study materials or patients: K. Squires, A.L. Pozniak, G. Pierone, C.R. Steinhart, D. Berger, N.C. Bellos, S.L. Becker.

Statistical expertise: M. Wulfsohn.

Collection and assembly of data: G. Pierone, J.J. Toole.


Ann Intern Med. 2003;139(5_Part_1):313-320. doi:10.7326/0003-4819-139-5_Part_1-200309020-00006
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In this study, we compared tenofovir DF with placebo when either was added to existing antiretroviral therapy in patients with stable HIV-1 RNA levels between 400 and 10 000 copies/mL. This design allowed us to rigorously assess the efficacy and safety profiles of tenofovir DF in treatment-experienced patients who had low but stable levels of viral replication despite ongoing treatment. Patients with HIV-1 RNA levels greater than 10 000 copies/mL were excluded from the study. The 6-month use of a placebo control is not consistent with current clinical practice in patients with an unstable, failing antiretroviral regimen and would put them at undue risk for rapid development of additional HIV-1 resistance mutations and probable clinical progression of HIV disease.

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Grahic Jump Location
Figure. Tenofovir DF = tenofovir disoproxil fumarate.
Recruitment and disposition flow chart.
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Summary for Patients

Treatment for Resistant HIV-1 Infection

The summary below is from the full report titled “Tenofovir Disoproxil Fumarate in Nucleoside-Resistant HIV-1 Infection.” It is in the 2 September 2003 issue of Annals of Internal Medicine (volume 139, pages 313-320). The authors are K. Squires, A.L. Pozniak, G. Pierone Jr., C.R. Steinhart, D. Berger, N.C. Bellos, S.L. Becker, M. Wulfsohn, M.D. Miller, J.J. Toole, D.F. Coakley, and A. Cheng, for the Study 907 Team.

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