Can further placebo-controlled trials of antiretroviral drugs to prevent sexual transmission of HIV be justified?

The Lancet

Volumn 378, Issue 9787, 2011, Pages 285-287

  Kuhn, Louise ^a   Susser, Ida ^b   Stein, Zena ^c  

^a Department of Medicine   (United States)

^b CITY UNIVERSITY OF NEW YORK   (United States)

^c NEW YORK STATE PSYCHIATRIC INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; EMTRICITABINE PLUS TENOFOVIR; MICROBICIDE; ORAL CONTRACEPTIVE AGENT; PLACEBO; UNCLASSIFIED DRUG;

BRAZIL; CASE CONTROL STUDY; DRUG EFFICACY; DRUG EXPOSURE; ECUADOR; HEALTH CARE PERSONNEL; HIGH RISK POPULATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMAN IMMUNODEFICIENCY VIRUS PREVALENCE; MALE HOMOSEXUAL; MALE TO FEMALE TRANSSEXUAL; MOTHER CHILD RELATION; NEEDLESTICK INJURY; NONHUMAN; OCCUPATIONAL EXPOSURE; PERU; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REVIEW; RISK REDUCTION; SEXUAL INTERCOURSE; SEXUAL TRANSMISSION; SOUTH AFRICA; THAILAND; UNITED STATES; VIRUS TRANSMISSION;

EID: 79960350190     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(11)60134-7     Document Type: Note

References (16)

1. KQ Abdool, SS Abdool Karim, JA Frohlich for the CAPRISA 004 Trial Group Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women Science 329 2010 1168 1174
2. RM Grant, JR Lama, PL Anderson for the iPrEx Study Team Preexposure chemoprophylaxis for HIV prevention in men who have sex with men N Engl J Med 363 2010 2587 2599
3. National AIDS Treatment Advocacy Project CONRAD. FDA and CONRAD chart U.S. regulatory path for 1 tenofovir gel for HIV prevention: FDA has granted fast track approval designation for 1 tenofovir gel http://www.natap.org/2010/ newsUpdates/110110-01.htm Oct 25, 2010 (accessed Jan 14, 2011).
4. Williams BG, Abdool Karim SS, Gouws E, Abdool KQ. Impact of tenofovir gel on the HIV epidemic in South Africa: A mathematical model to estimate the effect of the CAPRISA 004 microbicide trial results. XVIII International AIDS Conference; Vienna, Austria; July 18-23, 2010. LBPE27.
5. Z Stein, I Susser Transparency, accountability, and feminist science - what next for microbicide trials? http://www.athenanetwork.org/assets/files/ microbicide-0215.pdf October, 2010 (accessed April 19, 2011).
6. UM Parikh, C Dobard, S Sharma et al. Complete protection from repeated vaginal simian-human immunodeficiency virus exposures in macaques by a topical gel containing tenofovir alone or with emtricitabine J Virol 83 2009 10358 10365
7. ME Roland Postexposure prophylaxis after sexual exposure to HIV Curr Opin Infect Dis 20 2007 39 46 (Pubitemid 46052125)
8. TN Young, FJ Arens, GE Kennedy, JW Laurie, G Rutherford Antiretroviral post-exposure prophylaxis (PEP) for occupational HIV exposure Cochrane Database Syst Rev 1 2007 CD002835.
9. Centers for Disease Control and Prevention (CDC) Case-control study of HIV seroconversion in health-care workers after percutaneous exposure to HIV-infected blood - France, United Kingdom, and United States, January 1988-August 1994 MMWR Morb Mortal Wkly Rep 44 1995 929 933
10. MA Thompson, JA Aberg, P Cahn for the International AIDS Society-USA Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel JAMA 304 2010 321 333
11. LM Mofenson Antiretroviral drugs to prevent breastfeeding HIV transmission Antivir Ther 15 2010 537 553
12. GM Aldrovandi, L Kuhn What infants and breasts can teach us about natural protection from HIV infection J Infect Dis 202 suppl 3 2010 S366 S370
13. EM Connor, RS Sperling, R Gelber et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group N Engl J Med 331 1994 1173 1180 (Pubitemid 24331334)
14. UNICEF, UNAIDS, WHO, UNFPA, UNESCO Children and AIDS: fifth stocktaking report, 2010 http://www.unicef.org/aids/files/ChildrenAndAIDS-Fifth-Stocktaking- Report-2010-EN.pdf November, 2010 (accessed April 1, 2011).
15. P Lurie, SM Wolfe Science, ethics, and future of research into maternal-infant transmission of HIV-1 Lancet 353 1999 1878 1879
16. FHI FHI to initiate orderly closure of FEM-PrEP http://www.fhi.org/en/ Research/Projects/FEM-PrEP.htm April 18, 2011 (accessed April 19, 2011).