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HIV and Emerging Infectious Diseases Program

Healthy Volunteer Studies

Studies of healthy volunteers are crucial to the understanding and treatment of diseases. They provide a baseline for measuring the extent of disease and provide important information about the safety and effectiveness of various treatments. The National Institutes of Health (NIH) houses the nation’s most renowned biomedical research institutions. The following clinical research studies are being conducted by NIAID and the NIH Clinical Center in Bethesda, Maryland.

Phase I Study of Safety and Immunogenicity of Ad4-HIV Vaccine Vectors in Healthy Volunteers

(NACHO, Protocol 14-I-0011)

The purpose of this study is to test experimental HIV vaccines to see if they are safe. HIV (human immunodeficiency virus) is the virus that causes AIDS (acquired immune deficiency syndrome). The vaccines use a live adenovirus as a carrier (or transporter). Adenoviruses are naturally occurring viruses that typically cause symptoms of a cold or conjunctivitis (a superficial eye infection). We hope that the adenovirus carrier will help the vaccines stimulate an immune response against HIV. An immune response is the body’s release of cells and substances that protect the body from infection and foreign matter. Another important goal is to see whether different ways of giving the vaccines cause different immune responses. We also want to see if the adenovirus in the vaccines is contagious or spreads to others. The study vaccine will not expose you to HIV infection. Volunteers will be compensated.​

Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted with Cobicistat in Healthy Volunteers

(R2D2 – Protocol #16-CC-0112)

People infected with human immunodeficiency virus (HIV) often take several anti-HIV medications to control their disease. They may also need to take medications to treat a type of infection called latent tuberculosis (TB). There are a number of medications that can be used to treat latent TB. Most of these have to be taken multiple times a week or every day. However, there is a once weekly treatment for latent TB that would be easier for people with HIV to take.

The once weekly TB treatment consists of two drugs: isoniazid and rifapentine. Pyridoxine (vitamin B6) may also be given to prevent side effects from isoniazid. Isoniazid and rifapentine may increase or decrease the blood levels of some anti- HIV drugs. These changes could either increase drug side effects or make the anti-HIV treatment not work. However, since isoniazid and rifapentine are given only once a week, they may not affect the anti-HIV drug levels at all. It is important to know how anti-HIV and anti-TB drugs affect each other so that people taking these drugs together can be treated safely.

We will recruit up to 35 subjects who are HIV-negative, healthy individuals between 18 and 65 years of age. Volunteers must be in good general health. Volunteers will be compensated.

A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults

(SAB-301 – Protocol #16-I-0119)

Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal respiratory illness. It's often spread through close contact with an infected person, and is caused by a virus. There are no vaccines and no treatments for MERS right now.

The main goal of this study is to evaluate an investigational (experimental) new therapy to possibly treat MERS. This possible treatment is called SAB-301. This possible treatment has not been approved by the Food and Drug Administration (FDA). This is the first time the SAB-301 is being studied in people. It is not like any of the other drugs currently approved by the FDA. The purpose of this study is to learn how safe and how well tolerated SAB-301 may be.

​We will recruit up to 38 subjects who are HIV-negative, healthy individuals between 18 and 60 years of age. Volunteers must be in good general health. Volunteers will be compensated.

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Last Updated May 24, 2016