Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

NIH to test maraviroc-based drug regimens for HIV prevention

19.07.2012
Safety, tolerability study to enroll MSM in the United States and Puerto Rico

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.

Maraviroc, manufactured by ViiV Healthcare, was approved by the U.S. Food and Drug Administration in 2007 to treat HIV/AIDS and has continued to demonstrate safety and effectiveness in HIV-infected individuals. The drug prevents HIV from entering cells, unlike tenofovir and emtricitabine, which interfere with HIV replication after the virus has infected a cell. Maraviroc rarely engenders resistance and although approved in the U.S. for use in patients beginning HIV treatment, it is not commonly used this way in a clinical setting.

For additional information about the NEXT-PrEP study, see the NEXT-PrEP Q&A (http://www.niaid.nih.gov/news/QA/Pages/NEXTPrEP.aspx). Information about the clinical trial is also available at http://www.clinicaltrials.gov under the identifier NCT01505114.

This study is being funded by grants numbers 5UM1AI068613-07, 5UM1AI068617-07 5UM1AI068619-07, 5UM1AI069465-06, 5UM1AI069466-06, 5UM1AI069480-05, and 5UM1AI069503-06 to HPTN; grants numbers 5UM1AI069415-06, 5UM1AI069419-06, 5UM1AI069424-06, 5UM1AI069434-06, 5UM1AI069494-06, 5UM1AI069501-06 and 5 UM1AI069534-06 to ACTG; and grant number 5UM1AI069423-06 to HPTN and ACTG jointly.

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 http://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 http://www.nih.gov.

Laura Sivitz Leifman | EurekAlert!
Further information:
http://www.niaid.nih.gov

More articles from Health and Medicine:

nachricht Structural framework for tumors also provides immune protection
26.02.2020 | Medical College of Georgia at Augusta University

nachricht Finding new clues to brain cancer treatment
21.02.2020 | Case Western Reserve University

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: High-pressure scientists in Bayreuth discover promising material for information technology

Researchers at the University of Bayreuth have discovered an unusual material: When cooled down to two degrees Celsius, its crystal structure and electronic properties change abruptly and significantly. In this new state, the distances between iron atoms can be tailored with the help of light beams. This opens up intriguing possibilities for application in the field of information technology. The scientists have presented their discovery in the journal "Angewandte Chemie - International Edition". The new findings are the result of close cooperation with partnering facilities in Augsburg, Dresden, Hamburg, and Moscow.

The material is an unusual form of iron oxide with the formula Fe₅O₆. The researchers produced it at a pressure of 15 gigapascals in a high-pressure laboratory...

Im Focus: From China to the South Pole: Joining forces to solve the neutrino mass puzzle

Study by Mainz physicists indicates that the next generation of neutrino experiments may well find the answer to one of the most pressing issues in neutrino physics

Among the most exciting challenges in modern physics is the identification of the neutrino mass ordering. Physicists from the Cluster of Excellence PRISMA+ at...

Im Focus: Therapies without drugs

Fraunhofer researchers are investigating the potential of microimplants to stimulate nerve cells and treat chronic conditions like asthma, diabetes, or Parkinson’s disease. Find out what makes this form of treatment so appealing and which challenges the researchers still have to master.

A study by the Robert Koch Institute has found that one in four women will suffer from weak bladders at some point in their lives. Treatments of this condition...

Im Focus: A step towards controlling spin-dependent petahertz electronics by material defects

The operational speed of semiconductors in various electronic and optoelectronic devices is limited to several gigahertz (a billion oscillations per second). This constrains the upper limit of the operational speed of computing. Now researchers from the Max Planck Institute for the Structure and Dynamics of Matter in Hamburg, Germany, and the Indian Institute of Technology in Bombay have explained how these processes can be sped up through the use of light waves and defected solid materials.

Light waves perform several hundred trillion oscillations per second. Hence, it is natural to envision employing light oscillations to drive the electronic...

Im Focus: Freiburg researcher investigate the origins of surface texture

Most natural and artificial surfaces are rough: metals and even glasses that appear smooth to the naked eye can look like jagged mountain ranges under the microscope. There is currently no uniform theory about the origin of this roughness despite it being observed on all scales, from the atomic to the tectonic. Scientists suspect that the rough surface is formed by irreversible plastic deformation that occurs in many processes of mechanical machining of components such as milling.

Prof. Dr. Lars Pastewka from the Simulation group at the Department of Microsystems Engineering at the University of Freiburg and his team have simulated such...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

70th Lindau Nobel Laureate Meeting: Around 70 Laureates set to meet with young scientists from approx. 100 countries

12.02.2020 | Event News

11th Advanced Battery Power Conference, March 24-25, 2020 in Münster/Germany

16.01.2020 | Event News

Laser Colloquium Hydrogen LKH2: fast and reliable fuel cell manufacturing

15.01.2020 | Event News

 
Latest News

Scientists 'film' a quantum measurement

26.02.2020 | Physics and Astronomy

Melting properties determine the biological functions of the cuticular hydrocarbon layer of ants

26.02.2020 | Interdisciplinary Research

Lights, camera, action... the super-fast world of droplet dynamics

26.02.2020 | Power and Electrical Engineering

VideoLinks
Science & Research
Overview of more VideoLinks >>>