YODA Healthy Volunteer Study

Study Name

Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers

Study Number

18-CC-0087

Goal of Study

People infected with HIV take drugs called antiretrovirals to keep the amount of HIV in their bodies low. HIV, which stands for human immunodeficiency virus, is the virus that causes AIDS. Many people with HIV also have a bacterial infection of the lungs called tuberculosis (TB). There are many medications that can be used to treat TB. Most of these treatments are complicated and are taken multiple times a week or every day. However, there is a simpler once-weekly treatment that consists of two drugs&# 8; rifapentine and isoniazid.

Rifapentine and isoniazid are known to increase or decrease the blood levels of some antiretrovirals. These changes could either increase drug side effects or make the antiretroviral not work. However, because rifapentine and isoniazid can be given only once a week, they may not affect the antiretroviral levels at all. It is important to know how antiretrovirals and anti-TB drugs affect each other so that people taking these drugs together can be treated safely.

In this study, we will look at whether rifapentine and isoniazid affect blood levels of a commonly used antiretroviral called tenofovir alafenamide, or TAF. The United States Food and Drug Administration (FDA) has approved rifapentine and isoniazid for treating TB. TAF is FDA approved for treating hepatitis B, and for treating HIV in combination with other antiretrovirals. You do not have TB, HIV or hepatitis B, so you do not need these drugs for your medical care. We are asking healthy people to join this study to evaluate the blood levels of TAF when taken with rifapentine with isoniazid and vitamin B6.  You will take the TAF once per day for 31 days, and rifapentine with isoniazid and vitamin B6 once per week for 3 weeks.

We will recruit up to 18 participants. Volunteers will be compensated.

Eligibility Criteria

• You are age 18-65 years old, HIV-negative, and in good general health
• You are willing to take the study medications described above
• If you are female, you are not pregnant or breast feeding, and you agree to avoid pregnancy during the study
• You do not take any prescription medications; some over-the-counter medications may be allowed
• You have no history of a serious illness
• You have never had or been treated for TB
• You do not smoke
• You agree not to use drugs or drink alcohol for the 46-day length of the study
• You can commit to approximately 10 visits to the NIH in Bethesda in a 46-day period
• You can commit to spending 8-10 hours at the NIH for four of those visits

Contact Information

Volunteer or get more information
Toll free: 1-800-411-1222
TTY: 1-866-411-1010
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Emailprpl@mail.cc.nih.gov

Participating in Research

Watch a series of short informational videos about participating in clinical trials. These videos are intended to help potential participants understand how research works, what questions they should consider asking, and things to think about when deciding whether or not to participate in a study.

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