Should We Embrace New Drugs with Open Arms? Experience from a Community-Based, Open-Arm, Randomized Clinical Trial of Combination Antiretroviral Therapy in Advanced HIV Disease

Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology

Volumn 13, Issue 5, 1996, Pages 422-426

  Montaner, Julio S G ^a,b,c   Hogg, Robert ^a,b   Srour, Leila F ^c   Murphy, Carol ^c   Barber, Clayton G ^a   Phillips, Peter ^a,b,c   O'Shaughnessy, Michael ^a,b,c   Schechter, Martin T ^a,b,c  

^a ST PAUL S HOSPITAL   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c Canadian HIV Trials Network   (Canada)

Author keywords

Combination therapy; Didanosine; Expanded access; Open arms; Randomized clinical trials; Zalcitabine; Zidovudine

Indexed keywords

DIDANOSINE; ZALCITABINE; ZIDOVUDINE;

ANTIBIOTIC THERAPY; ANTIVIRAL ACTIVITY; ARTICLE; CELL COUNT; CLINICAL ARTICLE; HELPER CELL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; IMMUNE DEFICIENCY; PATIENT CARE; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; STATISTICAL ANALYSIS; VIRUS INFECTION;

ADULT; ANTI-HIV AGENTS; BRITISH COLUMBIA; DIDANOSINE; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; PATIENT SELECTION; PHYSICIAN'S PRACTICE PATTERNS; PROSPECTIVE STUDIES; ZALCITABINE; ZIDOVUDINE;

HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS 1;

EID: 0030451157     PISSN: 10779450     EISSN: None     Source Type: Journal    
DOI: 10.1097/00042560-199612150-00004     Document Type: Article

References (25)

1. Nies AS. Principles of therapeutics. In: Goodman and Gilman, The pharmacological basis of therapeutics, 8th ed. New York: Pergamon Press, 1990:74-78.
2. Salisbury DA, Schechter MT. AIDS trials, civil liberties and the social control of therapy: should we embrace new drugs with open arms?. Can Med Assoc J 1990;142(10):1057-62.
3. Institute of Medical Ethics Working Party on the Ethical Implications of AIDS. AIDS, ethics and clinical trials. RW 1992;305:699-701.
4. Montaner JSG, Rachlis A, Beaulieu R, et al. The safety profile of didanosine (ddI) among patients with advanced HIV disease who are intolerant to or deteriorate despite zidovudine (ZDV) therapy. Results of the Canadian open ddI treatment program. J Acquir Immun Def Synd 1994;7(9):924-30.
5. Showron G, Squires K, Bowers J, et al. Safety of stavudine (d4T) in AZT intolerant subjects. VIII International Conference on AIDS/III STD World Congress, Amsterdam, July 1992; PoB3029:B91.
6. Schlech W, Beaulieu R, Gill J, Montaner JSG, Rachlis A. Canadian experience with ddC for advanced HIV-A infection in patients intolerant to ZDV or ddI. VIII International Conference on AIDS/ III STD World Congress, Amsterdam, July 1992; PoB3006:B88.
7. Pike IM, Nicaise C. The didanosine expanded access program: safety analysis. Clin Infect Dis 1993:16(suppl 1):S63-8.
8. Montaner JSG, Rachlis A, Zala C, et al. The safety profile of Stavudine (d4T) in advanced HIV infection-experience from the Canadian Expanded Access Program (EAP). 2nd National Conference on Human Retroviruses. Washington, DC, January 1995; Abstract 271:104.
9. Anderson RE, Dunkle LM, Smaldone L, et al. Design and implementation of the stavudine parallel-track program. JID 1995:171 (suppl 2):S118-122.
10. Levine L, Dubler NN, Levine RJ. Building a new consensus: ethical principles and policies for clinical research on HIV/AIDS. IRB 1991;13(1-2):1-17.
11. Delaney M. A case for patient access to experimental therapy. J Infect Dis 1989;159:4169.
12. Conway B, Montaner JSG, Raboud JM, et al. Immunological and virological effects of combination therapy with ZDV plus ddI or ddC. 3rd Conference on Retroviruses and Opportunistic Infections. Washington, DC, January 28-February 3, 1996. Abstract 288:106.
13. Heath KV, Montaner JSG, Hogg RS, Singer J, O'Shaughnessy MV, Schechter MT. Heterogeneity of HIV/AIDS therapeutic knowledge is associated with physician experience. Submitted to the XIth International Conference on AIDS, Vancouver, BC, Canada. July 7-12, 1996.
14. Richman DD. Public access to experimental drug therapy: AIDS raises yet another conflict between freedom of the individual and welfare of the individual and the public. J Infect Dis 1989:159: 412-5.
15. Hellman S, Hellman D. Of mice but not men. Problems of the randomized clinical trials. N Engl J Med 1991;324(22):1585-9.
16. Montaner JSG, Wainberg MA, O'Shaughnessy MV. In HIV-infected individuals who desire combination antiviral therapy zidovudine plus didanosine is preferred to zidovudine plus zalcitabine. Rev Med Virol 1994;4:9-12.
17. Carr A, Cooper DA. In HIV-infected individuals who desire combination antiviral therapy, zidovudine plus zalcitabine is preferred to zidovudine plus didanosine. Rev Med Virol 1994;4:5-8.
18. Hammer SM, Katzenstein DA, Hughes MD, Hirsch MS, Merigan TC for the ACTG 175 Virology Substudy Team. Virologic markers and outcome in ACTG 175. 3rd Conference on Retroviruses and Opportunistic Infections, Infectious Diseases Society of America. Washington, DC, January 28-February 1, 1996. Abstract 824:175.
19. Yeni P. Preliminary results of the European/Australia Delta trial: based on data up to 31st May, 1995 [Abstract]. Fifth European Conference on Clinical Aspects and Treatment of HIV Infection. Copenhagen, Denmark, September 1995.
20. O'Shaughnessy MV, Hogg RS, Strathdee SA, et al. The post-Concorde era: current trends in zidovudine utilization. Xth International Conference on AIDS. Yokohama, August 1994; Vol 1, Abstract 356B:16.
21. Ottenbacher K. Impact of random assignment on study outcome: an empirical examination. Controlled clinical trials. 1992;13(1):50-61.
22. Passamani E. Clinical trials - are they ethical? N Engl J Med 1991; 324(22):1589-91.
23. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5.
24. Bach MC. Clinical response to dideoxynosine in patients with HIV infection resistant to zidovudine. N Engl J Med 1990;323:275.
25. Stolley PD. The hazards of misguided compassion. Ann Intern Med 1993;118(10):822-3.