Establishing HIV treatment as prevention in the HIV Prevention Trials Network 052 randomized trial: An ethical odyssey

Clinical Trials

Volumn 9, Issue 3, 2012, Pages 340-347

  Cohen, Myron S ^a   McCauley, Marybeth ^b   Sugarman, Jeremy ^c  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b FAMILY HEALTH INTERNATIONAL   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRAL THERAPY; BIOETHICS; HEALTH CARE POLICY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; SEXUAL TRANSMISSION; STUDY DESIGN; THERAPY EFFECT;

ANTI-RETROVIRAL AGENTS; BIOMEDICAL RESEARCH; FEMALE; HETEROSEXUALITY; HIV INFECTIONS; HUMANS; MALE; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84862259969     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774512443594     Document Type: Review

References (39)

1. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365: 493-505.
2. Cohen MS, McCauley M, Gamble TR. HIV treatment as prevention and HPTN 052. Curr Opin HIV AIDS, 2012; 7: 99-105.
3. World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approach. WHO Press. Available at: http://www.who.int/hiv/pub/guidelines/artadultguidelines.pdf (2006, accessed September 2011).
4. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283: 2701-11. (Pubitemid 30337334)
5. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317: 141-45. (Pubitemid 17092151)
6. Miller FG, Brody H. A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep 2003; 33: 19-28.
7. Van der Graafand R, Van Delden JJM. Equipoise should be amended, not abandoned. Clin Trials 2011; 8: 408-16.
8. Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med 2000; 342: 921-29. (Pubitemid 30177052)
9. Cohen J. HIV treatment as prevention. Science 2011; 334: 1628.
10. Hawkins JS, Emanuel EJ. Clarifying confusions about coercion. Hastings Cent Rep 2005; 35: 16-19. (Pubitemid 43160425)
11. Emanuel EJ. Ending concerns about undue inducement. J Law Med Ethics 2004; 32: 100-05. (Pubitemid 39090116)
12. World Health Organization. The 3 by 5 initiative. Available at: http://www.who.int/3by5/en/
13. Global Fund to Fight AIDS, Tuberculosis, and Malaria. Available at: http://www.theglobalfund.org/en/
14. The United States President's Emergency Plan for AIDS Relief. Available at: http://www.pepfar.gov/
15. Randomized, Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings (PEARLS) Trial. Available at: http://clinicaltrials.gov/ct2/show/NCT00084136
16. Rennie S, Sugarman J, HPTN Ethics Working Group. Ethics guidance document for research. HIV Prevention Trials Network. Available at: http://www.hptn.org/ web%20documents/EWG/HPTNEthicsGuidance-V10Jun2009.pdf (2009, accessed September 2011).
17. Severe P, Juste MA, Ambroise A, et al. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. N Engl J Med 2010; 363: 257-65.
18. World Health Organisation. WHO handbook for guideline development. Geneva, March 2010. Available at: http://www.who.int/en/ (accessed March 2012).
19. Donnell D, Baeten JM, Kiarie J, et al. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: A prospective cohort analysis. Lancet 2010; 375: 2092-98.
20. Del Romero J, Castilla J, Hernando V, Rodríguez C, García S. Combined antiretroviral treatment and heterosexual transmission of HIV-1: Cross sectional and prospective cohort study. BMJ 2010; 340: c2205.
21. Das M, Chu PL, Santos GM, et al. Decreases in community viral load are accompanied by reductions in new HIV infections in San Francisco. PLoS One 2010; 5: e11068.
22. Dukers NH, Goudsmit J, de Wit JB, et al. Sexual risk behaviour relates to the virological and immunological improvements during highly active antiretroviral therapy in HIV-1 infection. AIDS 2001; 15: 369-78. (Pubitemid 32163823)
23. Jin F, Jansson J, Law M, et al. Per-contact probability of HIV transmission in homosexual men in Sydney in the era of HAART. AIDS 2010; 24: 907-13.
24. When To Start Consortium, Sterne JA, May M, et al. Timing of initiation of antiretroviral therapy in AIDS-free HIV-1-infected patients: A collaborative analysis of 18 HIV cohort studies. Lancet 2009; 373: 1352-63.
25. Smith K, Powers KA, Meussig KE, Miller WC, Cohen MS. ART and population-level HIV transmission: Ecology, observation, and interpretation. PloS Med, in press.
26. Eaton LA, Kalichman S. Risk compensation in HIV prevention: Implications for vaccines, microbicides, and other biomedical HIV prevention technologies. Curr HIV/AIDS Rep 2007; 4: 165-72.
27. Kitahata MM, Gange SJ, Abraham AG, et al. Effect of early versus deferred antiretroviral therapy for HIV on survival. N Engl J Med 2009; 360: 1815-26.
28. Cain LE, Logan R, Robins JM, et al. When to initiate combined antiretroviral therapy to reduce mortality and AIDS-defining illness in HIV-infected persons in developed countries: An observational study. Ann Intern Med 2011; 154: 509-15.
29. Sterne JA, Hernan MA, Ledergerber B, et al. Long-term effectiveness of potent antiretroviral therapy in preventing AIDS and death: A prospective cohort study. Lancet 2005; 366: 378-84. (Pubitemid 41073955)
30. Writing Committee for the CASCADE Collaboration. Timing of HAART initiation and clinical outcomes in Human Immunodeficiency Virus Type 1 seroconverters. Arch Intern Med 2011; 171: 1560-69.
31. World Health Organization. Rapid advice: Antiretroviral therapy for HIV infection in adults and adolescents. WHO Press. Available at: http://www.who.int/hiv/pub/arv/rapid-advice-art.pdf (2009, accessed September 2011).
32. Thompson MA, Aberg JA, Cahn P, et al. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society - USA Panel. JAMA 2010; 304: 321-33.
33. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services, 14 OCtober 2011, pp. 1-167. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf (accessed January 2012).
34. World Health Organization. Scaling up antiretroviral therapy in resource-limited settings: Guidelines for a public health approach. Available at: http://www.who.int/hiv/pub/guidelines/pub18/en/index.htm (2002, accessed January 2012).
35. Scientific Advisory Board, HPTN 052 Subcommittee, HPTN 052 Writing Group. PEPFAR scientific advisory board recommendations for the office of the US global AIDS coordinator: Implications of HPTN 052 for PEPFAR's treatment programs. Available at: www.pepfar.gov/documents/organization/177126.pdf (2011, accessed January 2012).
36. World Health Organization. WHO Consultation: The strategic use of antiretrovirals for treatment and prevention of HIV. Geneva, Switzerland, 14-16 November 2011. Executive summary. Available at: http://www.who.int/hiv/pub/ meetingreports/consultation-20111116/en/index.html (accessed March 2012).
37. Hughes J, Hudelson S, Redd A, et al. Analysis of genetic linkage of HIV from couples enrolled in the HIV Prevention Trials Network 052 trial. In Proceedings of the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention [Abstract], Rome, Italy, 17-20 July 2011.
38. Eshleman SH, Hudelson S, Redd AD, et al. Analysis of genetic linkage of HIV from couples enrolled in the HIV Prevention Trials Network 052 trial. J Infect Dis 2011; 204: 1918-26.
39. Taylor HA, Chaisson L, Sugarman J. Enhancing communication among data monitoring committees and institutional review boards. Clin Trials 2008; 5: 277-82.