Navigation Links
NIH to test maraviroc-based drug regimens for HIV prevention
Date:7/18/2012

Scientists are launching the first clinical trial to test whether drug regimens containing maraviroc, a medication currently approved to treat HIV infection, are also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection. The eventual goal is to see if the drug regimens can reduce the risk of infection.

The trial involves a strategy known as pre-exposure prophylaxis, or PrEP, in which HIV-uninfected individuals who are at risk for contracting the virus take one or two HIV drugs routinely in an effort to prevent infection. Called Novel Exploration of Therapeutics for PrEP, or NEXT-PrEP, the two-year study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

"The NEXT-PrEP study will examine whether maraviroc-based PrEP is safe and well-tolerated. It is a necessary first step before we can test the effectiveness of maraviroc-based PrEP, and in the future, potentially expand the selection of drugs that may be used in this emerging HIV prevention strategy," said NIAID Director Anthony S. Fauci, M.D.

Led by principal investigator Roy M. Gulick, M.D., M.P.H., chief of the Division of Infectious Diseases and professor of medicine at Weill Cornell Medical College of Cornell University, the study team will enroll 400 HIV-uninfected men who have sex with men (MSM) ages 18 and older in 12 cities in the United States and Puerto Rico. The volunteers will be assigned at random to take one of the following four PrEP study regimens daily for 48 weeks:

Maraviroc (300 milligrams)
Maraviroc (300 milligrams) plus emtricitabine (200 milligrams)
Maraviroc (300 milligrams) plus tenofovir disoproxil fumarate (300 milligrams)
Emtricitabine (200 milligrams) plus tenofovir disoproxil fumarate (300 milligrams)

Placebo pills will be added to the regimens 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 assess whether they continue taking their PrEP regimens as recommended. If the study drugs appear to compromise a participant'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.

The NIH-funded HIV Prevention Trials Network (HPTN), in collaboration with the AIDS Clinical Trials Group (ACTG), is conducting the NEXT-PrEP study, also called HPTN 069/ACTG 5305. Gilead Sciences Inc. of Foster City, Calif., and ViiV Healthcare of Brentford, England, are donating the study drugs.

This trial builds on the results of the NIAID-sponsored iPrEx study (http://www.niaid.nih.gov/news/newsreleases/2010/Pages/iPrEx.aspx), which found in 2010 that the daily PrEP regimen of oral tenofovir plus emtricitabine (brand name Truvada) reduced the risk of HIV infection in MSM by 43.8 percent.

The NEXT-PrEP study leaders chose to examine PrEP regimens containing maraviroc (brand name Selzentry) for several reasons. All other PrEP regimens tested to date involve tenofovir alone or in combination 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.


'/>"/>

Contact: Laura Sivitz Leifman
sivitzl@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert

Related medicine news :

1. UW study plays pivotal role in todays FDA approval of HIV prevention drug
2. Studies Show Value of AIDS Drugs as Prevention
3. Identifying risky behaviors: The key to HIV prevention
4. Prevention is better than cure for killer cardiovascular disease
5. Tufts Medical Center researchers receive $10 million NIH grant to test blood clot prevention drug
6. The prevention of hereditary breast and ovarian cancer by PGD is feasible
7. FirstVitals Health and Wellness, Inc. awarded $4 Million CMS Innovation Grant for Unique Telehealth Diabetes Progam Focused on Glycemic Control and Prevention of Diabetic Foot Complications
8. Researchers call for obesity prevention efforts to focus on community-wide systems
9. HIV prevention measures must include behavioral strategies to work, says APA
10. New guidelines deliver concise messages for implementing cardiovascular prevention
11. Better health in adulthood starts with early prevention in childhood
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/20/2017)... IN (PRWEB) , ... June 20, 2017 , ... ... benefits advisory organization, announces recipients of its annual “UBBIE” Awards (pronounced you-bee) for ... who have demonstrated significant achievements toward their involvement with UBA, the clients they ...
(Date:6/20/2017)... ... June 20, 2017 , ... ... services, has published a new eBook titled “ 5 Questions to Ask Before ... Research Analyst on the Genetic Test Evaluation (GTE) team, the book explores the ...
(Date:6/20/2017)... ... 2017 , ... EdChoice and the American Enterprise Institute each ... economic development in economically distressed urban areas. The first report presents a case ... the economic development of the city of Santa Ana, California. The second report ...
(Date:6/20/2017)... , ... June 20, 2017 , ... ... help content solutions for the enterprise, is proud to announce Touchpoints ... e-commerce, ticketing systems, company websites, and more to provide a seamless customer experience. ...
(Date:6/20/2017)... BC (PRWEB) , ... June 20, 2017 , ... As ... community on the link between stroke and gum disease. Those with bleeding gums in ... If left untreated, this condition can lead to heart disease, stroke and diabetes. Drs. ...
Breaking Medicine News(10 mins):
(Date:6/20/2017)... June 19, 2017  Hill-Rom Holdings, Inc. (NYSE: HRC), will ... webcast on Friday, July 28, 2017, beginning at 7:30 a.m. ... Only Dial-in information: To participate in the conference call, dial ... the call at least 10 minutes prior to the start ... Webcast: A simultaneous ...
(Date:6/14/2017)... -- The Bio Supply Management Alliance (BSMA) has announced ... and the Biomedical Manufacturing Network to advance the ... California by providing a platform for imparting ... development. The primary focus of this alliance is to ... as small and mid-sized biomedical companies. ...
(Date:6/10/2017)... K. Burchfield, DPM, is recognized by Continental Who,s Who as a ... Alabama . Dr. Burchfield serves as ... over 20 years of experience, as well as expertise in the ... "The podiatry professional ... to welcome you to his practice," the company,s website states. "We ...
Breaking Medicine Technology: