First, what I am clearly saying is, although many would like to have the "Prevention Pill," we don't have it yet. What we do have is some information based on studies with primates that says tenofovir has at least some preventive effect on infection of a simian (or monkey) version of HIV. We hope that there is some good news for humans in this, but we don't know.
Second, what we do know is tenofovir (or Viread®) has been well-tolerated by most of the persons with HIV who take it. We know it has been a very effective drug in stopping or slowing the virus from making copies of itself.
What we want to know is, what will tenofovir do to people who are not infected with HIV? So, Step One on this road to the preventive pill must be a study to prove it is safe for folks who are HIV-negative. That's "The T."
Tenofovir is a drug approved by the FDA. When it was studied before FDA approval, it was primarily studied in persons with HIV. We will study the safety of tenofovir in 400 men in our study. ARCA will enroll 200 of these men and, in keeping with where the epidemic is in Atlanta, we hope that half of these will be African-American. We are committed to including enough African-Americans to learn whether race affects the safety of this drug. The time is long overdue for African-Americans to have an important place at the table in the HIV research. ARCA is committed to this goal. (Women, also a critically important population, are being studied in overseas trials.)
We believe tenofovir will be safer to administer as a daily dose than many of the other drugs currently used to fight the virus. For most people who take tenofovir, it appears to cause minimal or no side effects. In some HIV+ persons, there have been incidences of kidney effects and the possible loss of bone mass. The participants in the study will be closely monitored, especially for potential kidney problems, which will help determine if this side effect is present in people without HIV and whether it will limit tenofovir's usefulness as the possible prevention tool we need.
Oh, I said it. We need a new prevention tool! Despite 20 years of advocating, educating and doing all manner of condom shows, displays and how-to's, many people around the world, for all sorts of reasons, have found that as a prevention option, condoms -- whether colored, flavored, ribbed, lubed, easy-to-open, large, small, tight, loose, latex or polyurethane -- are less than favorable to unacceptable. We are still challenging cultural biases, religious teaching and personal dislike of anything that is perceived to disrupt the intimacy of sex between two people. So condoms alone aren't doing it, mainly because people are not using them.
Pardon me, perhaps I should have said we need another prevention tool in addition to abstinence (having no sex at all, ever) and having monogamous sex with an uninfected individual. The last two methods are very effective regardless of their limited appeal. And let's be clear that the use of the word monogamous is in its strictest meaning: a long-term relationship with one other person. There are many different personal definitions that do not quite match with this.
"The T" was developed with intensive community involvement. Our Atlanta community supports "The T," and I think it is because we are all very tired of HIV/AIDS. We thought this disease would be well over by now. Certainly, we thought that the conversation would be about the word cure after 20 years, not about testing new prevention tools. Therefore, we still have the need not only worldwide but also in our own neighborhoods to have something that will help, even if it is down the road a bit, with preventing new infections.
So, if you are a man who has sex with men (or know one), who is single or not tied down in a monogamous relationship with another HIV-negative man, consider being part of the study. We will monitor all the participants closely to safeguard their health. We will offer free testing and counseling anytime you would like, and there is a small compensation available for attending visits. And as always, we encourage you to practice sex safely.
I am convinced that our communities would love to know if "The T" is going to help us get another tool to prevent the further spread of HIV. For more information regarding the study and to see if you can be a participant, please call ARCA at (404) 876-2317 or e-mail us at WhatsTheT@aidsresearchatlanta.org.