NEXT-PrEP, [Novel Exploration of Therapeutics (NEXT) for Pre-Exposure Prophylaxis (PrEP)], also known as the HPTN 069/ACTG 5305 study, is an HIV prevention study that is being done to learn more about the safety and acceptability of four different drug combinations when used as PrEP by men who have sex with men and by women who have sex with men. PrEP is a new HIV prevention method in which people who are HIV-negative take HIV treatment drugs (antiretrovirals – ARVs) daily to reduce their risk of becoming HIV-infected. All of the drugs used in the study are approved by the Food and Drug Administration (FDA) to treat people with HIV infection. The drugs in this study are called maraviroc (also called Selzentry or MVC), emtricitabine (also called Emtriva or FTC), and tenofovir (also called Viread or TDF).

The NEXT-PrEP study is an important next step in helping to determine if future research should be done to see if different ARVs can be used as PrEP. There are some concerns about the possibility of side effects and resistance related to the ARVs that are currently used for PrEP. Resistance means that some strains of HIV can no longer be treated with certain ARVs. Maraviroc is an approved drug that blocks entry of HIV into cells. It has been shown to be safe for use by HIV-positive people and rarely causes drug resistance. This will be the first study to see if maraviroc is safe and tolerable when used by HIV-negative people as an HIV prevention strategy. The results of the NEXT-PrEP study will help researchers decide if maraviroc should be tested further to see if it prevents new HIV infections when it is used as PrEP.

You can get more information about the NEXT-PrEP study by visiting the HIV Prevention Trials Network (HPTN) website at www.HPTN.org.

If you believe that you are HIV negative, and if you live in one of the following communities, contact the research site in your area and they will help you find out if you are eligible and guide you through the process of volunteering.

• Baltimore, MD
• Boston, MA
• Chapel Hill, NC
• Cleveland, OH
• Los Angeles, CA
• Newark, NJ (only enrolling women)
• New York, NY
• Philadelphia, PA
• Pittsburgh, PA
• San Francisco, CA (only enrolling MSM and transgender women)
• San Juan, PR
• Seattle, WA
• Washington, DC

Information about the study that is provided on the HPTN website (www.HPTN.org) is available to the public. You do not need to login or provide any personal information to access those pages. If you choose to contact a research site in your area any personal information that you provide will be strictly protected. Research site members will take steps to protect your confidentiality. You can always refuse to answer any questions that you do not want to answer, and you may discontinue contact at any time.

NEXT-PrEP will help us to understand the safety and tolerability of the drugs being used in the study. HIV-negative people will take one of four different combinations of ARV drugs. Each person who becomes a study volunteer will be randomly assigned (like pulling numbers out of a hat) to one of the four groups. All participants will take three pills every day. Each group will receive at least one active drug in their set of three daily pills. All of the pills, including those which are inactive (called placebos) will look exactly like the real pills. The researchers and participants will not know which group people are in or which drugs the participants are taking. This is because the researchers do not want to have any influence on how the results of the study will come out.

All study participants will be observed to see if they experience any side effects. Though it is not expected, if there are any serious side effects reported for any of the groups, individuals in that group will be told to stop taking the drugs.

In addition to taking the PrEP regimens, participants will be told that one of the best things they can do to protect themselves from getting HIV and other sexually transmitted infections (like gonorrhea, syphilis or chlamydia) is to use a condom every time they have sex.

Participants will be in the study for about one year, and will meet with members of their local study team about 10 times over the course of that year. At these visits the study team will provide a physical exam, check the health of their liver, bones and kidneys, and discuss any concerns or side effects that may be related to the study drugs. All participants will receive HIV prevention counseling, and an HIV test and condoms at each study visit.

Yes. Participants will need to take medications as part of this research project. Please see the question "What does participating in the NEXT-PrEP study involve?" shown above for more information about the medications.

Yes, testing will be available. All people who are interested in volunteering will be required to take an HIV test to confirm their HIV status prior to enrolling in the study.

You can find information about local testing and treatment sites by going to www.aids.gov and typing your zip code into the 'Get Tested. Get Services' search bar. This locator service will also provide information about other resources, such as mental health care, housing assistance and health care services. The AIDS.gov website was created by the US Department of Health and Human Services. You can also find more local information about HIV and STI testing and care by contacting the health department in your area.

NEXT-PrEP is funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). The study is a collaboration between the HIV Prevention Trials Network (HPTN) and the AIDS Clinical Trials Group (ACTG). Gilead Sciences and ViiV Healthcare are donating the study drugs.

The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the acquisition and transmission of HIV. HPTN is funded by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). More information about HPTN can be found at www.HPTN.org. HPTN is also on Facebook at www.facebook.com/HIVptn and on Twitter at twitter.com/HIVptn.

The AIDS Clinical Trials Group (ACTG) was initially established in 1987 to broaden the scope of the AIDS research effort of the National Institute of Allergy and Infectious Diseases (NIAID). The ACTG established and supports the largest Network of expert clinical and translational investigators and therapeutic clinical trials units in the world, including sites in resource-limited countries. These investigators and units serve as the major resource for HIV/AIDS research, treatment, care, and training/education in their communities.

The ACTG is funded by the Department of Health and Human Services, National Institutes of Health through the National Institute of Allergy and Infectious Diseases (grant number AI-68636). More information about ACTG can be found at www.actgnetwork.org. ACTG is also on Facebook at www.facebook.com/AIDSClinicalTrialsGroup and on Twitter at www.twitter.com/ACTGNetwork.