Skip Navigation

News & Events


July 18, 2012

Skip Content Marketing
  • Share this:
  • submit to facebook
  • Tweet it
  • submit to reddit
  • submit to StumbleUpon
  • submit to Google +

QUESTIONS AND ANSWERS
The NEXT-PrEP HIV Prevention Study


1.   What is the NEXT-PrEP study?
   
The NEXT-PrEP (“Novel Exploration of Therapeutics for PrEP”) study is a clinical trial designed to test whether the antiretroviral drug maraviroc, currently approved to treat HIV infection, is also safe and tolerable when taken once daily, alone or in combination with another antiretroviral drug, by HIV-uninfected individuals at increased risk for acquiring HIV infection. The study is also known as HPTN 069 or ACTG 5305.

2.   What is PrEP?
   
PrEP is short for “pre-exposure prophylaxis,” an HIV-prevention strategy in which HIV-uninfected individuals at risk for contracting the virus routinely take one or more HIV drugs in an effort to prevent infection. Scientists theorized that taking an antiretroviral drug before exposure to the virus can block HIV infection or inhibit replication of the virus immediately after exposure to it, thereby thwarting the establishment of permanent infection.

 

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.

3.   Who is participating in the NEXT-PrEP study?
   
The study team plans to enroll 400 MSM ages 18 and older in the United States and Puerto Rico. Special emphasis will be placed on enrolling MSM of color and those ages 18 to 25—populations that are disproportionately affected by the U.S. HIV epidemic.

4.   Who is sponsoring and funding the NEXT-PrEP study?
     
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is sponsoring and funding the NEXT-PrEP study. Gilead Sciences Inc. of Foster City, Calif., and ViiV Healthcare of Brentford, U.K., are donating the study drugs.

5.   Who is conducting the NEXT-PrEP study?
 
The NIH-funded HIV Prevention Trials Network (HPTN), in collaboration with the AIDS Clinical Trials Group (ACTG), is conducting the NEXT-PrEP study under the leadership of Roy M. Gulick, M.D., M.P.H., professor of medicine and chief of the Division of Infectious Diseases at Weill Medical College of Cornell University. Dr. Gulick is joined by two co-principal investigators: Kenneth Mayer, M.D., professor of medicine and community health at the Alpert Medical School of Brown University and medical research director of Fenway Health; and Timothy Wilkin, M.D., associate professor of medicine at Weill Medical College of Cornell University.

6.   Where is the NEXT-PrEP study taking place?
   

The study is taking place in 12 cities in the United States and Puerto Rico:

Baltimore, Md.
Boston, Mass.
Chapel Hill, N.C.
Cleveland, Ohio
Los Angeles, Calif.
New York, N.Y.
Philadelphia, Pa.
Pittsburgh, Pa.
San Francisco, Calif.
San Juan, Puerto Rico
Seattle, Wash.
Washington, D.C.
7.   When did the study begin, and when are results expected?
   
The study launched in July 2012, and results are expected in mid-2014.

8.   What is the study design?
   
The NEXT-PrEP study is a Phase II, four-arm, randomized, double-blind clinical trial. This means that neither the participants nor the investigators will know who is taking which drug regimen. Study participants will be assigned at random to take one of the following four PrEP regimens for 48 weeks:

 

  • Maraviroc (300 mg)
  • Maraviroc (300 mg) plus emtricitabine (200 mg)
  • Maraviroc (300 mg) plus tenofovir disoproxil fumarate (300 mg)
  • Emtricitabine (200 mg) plus tenofovir disoproxil fumarate (300 mg)

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.

9.   Why is maraviroc being tested for use as a PrEP regimen?
   
The NEXT-PrEP study leaders chose to examine PrEP regimens that contain maraviroc (brand name Selzentry) for several reasons. All other PrEP regimens tested to date have involved tenofovir either alone or with emtricitabine. Concerns about potential toxicity and the development of drug resistance suggested to the scientists that a wider array of antiretroviral drugs with optimal properties for HIV prevention should be explored.

 

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.

10.   How will the NEXT-PrEP study team ensure the safety of study participants?
   
Site investigators are closely and continuously monitoring safety data and will alert the Protocol Safety Review Team to any safety concerns, should they arise. The Protocol Safety Review Team is meeting monthly to review reports on safety-related study data and will respond promptly to any concerns.

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



Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health ®

back to top


Last Updated July 26, 2012

Last Reviewed July 26, 2012