July 18, 2012
On July 16, 2012, the Food and Drug Administration approved the use of the HIV drug combination tenofovir and emtricitabine (brand name Truvada) for HIV prevention. This decision was based in part on data from several studies, including the NIAID-sponsored iPrEx study, demonstrating the safety and effectiveness of a daily oral dose of tenofovir or Truvada at preventing HIV infection in men who have sex with men (MSM), transgender women who have sex with men, and heterosexual men and women.
Two other studies, including the NIAID-sponsored VOICE study, found no difference between a placebo pill and either tenofovir or Truvada at preventing HIV infection in women.
The study is taking place in 12 cities in the United States and Puerto Rico:
Placebo pills will be added as needed so that neither the participants nor the study team will know who is taking which regimen. The investigators will observe whether the volunteers experience any serious side effects and will assess whether the participants continue taking their PrEP regimens as recommended. If the study drugs appear to compromise a volunteer’s health, he will be directed to stop taking them.
All participants will regularly be tested for HIV infection and receive condoms and counseling on how to reduce their risk of becoming infected with the virus. This will occur at enrollment; 2, 4 and 8 weeks after starting PrEP; and every 8 weeks thereafter. Any participant who acquires HIV infection during the study will be instructed to stop taking his assigned PrEP regimen to prevent the development of drug resistance and will be referred for counseling and medical care.
The NEXT-PrEP clinical trial will have two sub-studies. One will evaluate potential interactions among the three drugs under study, and the other will evaluate the systemic and tissue pharmacology of these drugs.
Maraviroc, manufactured by ViiV Healthcare, was approved by the Food and Drug Administration in 2007 for the treatment of HIV/AIDS and has demonstrated continued safety and effectiveness since that time. Unlike tenofovir and emtricitabine, which interfere with HIV replication after the virus has infected a cell, maraviroc prevents HIV from entering cells in the first place. Moreover, maraviroc rarely engenders resistance and is not currently recommended for first-line therapy. In addition, studies have shown that maraviroc prevents HIV infection in a humanized mouse model, and it also penetrates and concentrates well in tissues of the human cervix, vagina and rectum.
For more information about the NEXT-PrEP study, see www.clinicaltrials.gov using the identifier NCT01505114. Information is also available on the HPTN Web site.
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Last Updated July 26, 2012
Last Reviewed July 26, 2012