HIV and Emerging Infectious Diseases Program Clinical Studies

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:

Clinical Outcomes of Patients with HIV Acquired in Early Life

(COPE – Protocol #12-I-0157)

We would like to better understand how HIV infection and the medicines used to treat it affect the growth and development of youth and young adults who have been infected since early life. We want to find out if there are any problems with how HIV-infected children grow and develop as adults, particularly with regard to cardiovascular health. We are interested in studying your heart because HIV appears to be associated with an increased risk of heart disease. Volunteers will be compensated.​

Characterization and Management of Patients With HIV-1 Infection Who Experience Virologic Failure Despite Combination Antiretroviral Therapy

(DOTCOM – Protocol #14-I-0009)

NIH is conducting a research study for people whose HIV infection is not currently under control, despite taking HIV medications. In general, the medicine used to treat HIV infection called antiretroviral therapy (ART) can decrease the amount of HIV virus in your blood (also called viral load or HIV RNA) to a very low level. This only happens if the ART drugs used still work to fight off the HIV virus from your body, and if you are taking the ART drugs every day, as instructed by your primary care doctor. When ART drugs no longer work against the HIV virus, the virus is said to become “resistant” to the drugs. We are interested in learning more about how to control HIV infection in people who can’t get a lower viral load despite receiving ART drugs.

A total of 100 subjects, 14 years of age or older, are expected to join the study. To be in the study, you must have a primary care doctor, and be willing to be hospitalized for the inpatient stays, have your blood samples stored, and undergo genetic testing. The study is currently open only to residents in the DC Metro area who can travel to NIH in Bethesda, Maryland. Volunteers may be compensated.

Elite Controller and ART-Treated HIV+ Statin versus ASA Treatment Intervention Study

(ECSTATIN 14-I-0039)

​NIH is conducting a study that will look at changes in the body’s immune and clotting system markers. The immune system is made up of cells and substances that protect the body from infection and foreign matter. The activation of the immune system (or inflammation) can sometimes be harmful. Similarly, the clotting system is what makes the blood clot and protects us from bleeding but can be sometimes harmful if it is inappropriately activated. In chronic HIV infection, there is increased inflammation and coagulation (clotting) that may put people at higher risk for cardiovascular diseases such as stroke or heart attacks. Our goal is to study how immune and clotting system markers may change in people infected with HIV after receiving 9 months of a daily dose of aspirin (a medication that decreases clotting and inflammation) or atorvastatin (a medication which lowers blood cholesterol and decreases inflammation). As part of the study we will also examine your carotid vessels (the major blood vessels that supply blood to the neck and head) by magnetic tomography to look at the thickness of the vessel wall. Volunteer compensation and study medications will be provided.

Leukapheresis Procedures to Study HIV-Specific Immunity

(LTNP – Protocol #02-I-0086)

We will evaluate patients who have been able to control the progression of HIV for long periods without the use of antiretroviral therapy. Some immune system-related genes have been identified in people who are often labeled “long-term non-progressors” (LTNP). These HLA genes include B27, B35, B44, B57, B58, and/or A02. We will conduct genetic testing, blood collection, and tissue sampling in the hope of better understanding how some rare individuals can suppress HIV without medications. Volunteers will be compensated.

PET Imaging and Lymph Node Assessment of IRIS in Persons with AIDS

(PANDORA – Protocol # 14-I-0124)

This study will look for the development of IRIS (Immune Reconstitution Inflammatory Syndrome), a condition that can happen in patients who are infected with HIV, after they begin treatment with antiretroviral therapy (ART). Taking these drugs can lead to a rapid improvement in the body's ability to fight infections, but this sudden improvement can cause some or all of the symptoms of a disease that the patient already has to become worse, or cause new symptoms to appear. As an example patients can develop fever, large lymph nodes, or other complications, or a new disease can be diagnosed that was silent before ART.

​A total of 100 subjects are expected to join the study. Volunteers may be compensated for study procedures.

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naïve HIV-Infected Patients

(RPHI – Protocol #02-I-0202)

Determining how the immune system of some patients is able to control HIV is felt to be a very important step for designing vaccines and therapies for HIV. A certain number of patients who are treated with highly active antiretroviral therapy (HAART) early during HIV infection have been able to maintain their immunity against HIV, and in a subcategory of patients, early treatment allows patients to stop their medication while preventing their virus from returning to unsafe levels. Our laboratory is recruiting HIV-infected patients to further understand the mechanism(s) involved in maintenance of immune function following early intervention with antiretroviral therapy. In addition, for purposes of comparison, patients who have passed the early stage of HIV infection are also being recruited. Volunteers will be compensated. ​

Tesamorelin Effects on Liver Fat and Histology in HIV

(TESLA – Protocol #15-I-0036)

Tesamorelin Effects on Liver Fat and Histology in HIV. The study is for people with HIV and are known or suspected to have non-alcoholic fatty liver disease, or NAFLD. NAFLD is a common health problem in people with HIV. It is a type of liver disease in which there is a build-up of fat in the liver, leading to liver inflammation. This damages the liver and can lead to liver cancer or liver failure. In addition to liver damage, NAFLD has been associated with increased belly fat and may raise the risk for heart disease and diabetes.

​Currently, no drugs are specifically approved to decrease liver fat in HIV-infected patients with NAFLD. Other research studies suggest that a drug called tesamorelin (Egrifta) reduces liver fat in people with HIV. Tesamorelin has been approved by the Food and Drug Administration (FDA) to decrease belly fat in HIV-infected people with an abnormal distribution of fat tissue. It works by stimulating the body to release a hormone that causes the breakdown of excess fat. The main purpose of this research study is to test if tesamorelin will reduce liver fat in HIV-infected patients with NAFLD. We also want to see if tesamorelin will reduce liver inflammation and signs of liver damage. In addition, we want to study how tesamorelin works in this population. Volunteers will be compensated.

A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients with Chronically Elevated Transaminases on Antiretroviral Therapy

(TRANSAM – Protocol #06-I-0153)

NIH is conducting a research study to evaluate HIV-positive patients, aged 18 and older, (without HBV or HCV co-infection) with chronically elevated hepatic transaminases while on HAART for evidence of fibrosis or other liver pathology by examining liver biopsy specimens. The study will include a screening visit, physical exam, laboratory tests, abdominal CT, and a liver biopsy procedure. A specialized ultrasound to look at liver stiffness may also be performed. There will be up to four visits prior to liver biopsy and four follow-up visits after biopsy. Financial compensation will be provided for visits completed.

An Exploratory, Open-Label Study of Vedolizumab in Subjects with HIV Infection Undergoing Analytical Treatment Interruption

(VEDOMAB– Protocol #16-I-0118)

The NIH is conducting a research study for people with HIV on HIV medications.  In most people infected with HIV, their immune system can't control or cure the infection. Combination antiretroviral therapy ('cART' – a combination of anti-HIV drugs taken daily) can keep the amount of HIV virus very low for a long time. However, if treatment is stopped, the immune system isn't able to control the infection, and HIV levels go up again. People who take cART can also develop resistance to the medications or have permanent side effects.

The main purpose of this study is to see if the drug vedolizumab is safe and if it can control the amount of HIV in your blood when you are not taking your cART. Vedolizumab is currently FDA-approved for use in people with ulcerative colitis or Crohn's disease, under the trade name Entyvio.  We do not know if it will be effective for controlling HIV, so its use in this study is experimental. Levels of HIV, CD4 cells (the 'good' immune cells that are damaged by HIV), and other measures of HIV infection will be monitored after you receive this product and have stopped taking your cART.

A total of 15 individuals between the ages of 18-65 are expected to participate in this study.  Volunteers will be compensated.​


Non-Viral Liver Studies

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:

A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients with Chronically Elevated Transaminases on Antiretroviral Therapy

(TRANSAM – Protocol #06-I-0153)

NIH is conducting a research study to evaluate HIV-positive patients age 18 and older (without HBV or HCV co-infection) who have chronically elevated hepatic transaminases while on HAART, for evidence of fibrosis or other liver pathology, by examining liver biopsy specimens. The study will include a screening visit, a physical exam, laboratory tests, an abdominal CT, and a liver biopsy procedure. A specialized ultrasound to look at liver stiffness may also be performed. There will be up to four visits before liver biopsy and four follow-up visits after biopsy. Financial compensation will be provided for visits completed.

Tesamorelin Effects on Liver Fat and Histology in HIV

(TESLA – Protocol #15-I-0036)

Tesamorelin Effects on Liver Fat and Histology in HIV. The study is for people with HIV and are known or suspected to have non-alcoholic fatty liver disease, or NAFLD. NAFLD is a common health problem in people with HIV. It is a type of liver disease in which there is a build-up of fat in the liver, leading to liver inflammation. This damages the liver and can lead to liver cancer or liver failure. In addition to liver damage, NAFLD has been associated with increased belly fat and may raise the risk for heart disease and diabetes.

Currently, no drugs are specifically approved to decrease liver fat in HIV-infected patients with NAFLD. Other research studies suggest that a drug called tesamorelin (Egrifta) reduces liver fat in people with HIV. Tesamorelin has been approved by the Food and Drug Administration to decrease belly fat in HIV-infected people with an abnormal distribution of fat tissue. It works by stimulating the body to release a hormone that causes the breakdown of excess fat. The main purpose of this research study is to test if tesamorelin will reduce liver fat in HIV-infected patients with NAFLD. We also want to see if tesamorelin will reduce liver inflammation and signs of liver damage. In addition, we want to study how tesamorelin works in this population. Volunteers will be compensated.


Healthy Volunteer Studies

If your are interested in volunteering, please fill our our confidential eligibility questionnaire.

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.


Idiopathic CD4 Lymphocytopenia (ICL) studies

Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia

(EPIC – Protocol #09-I-0102)

The primary objective of this study is to further characterize the natural history of idiopathic CD4 lymphocytopenia (ICL) while also investigating the genetic, environmental, and immunologic features of the condition. During your participation in this study, we will be collecting your blood in order to study the numbers and function of your CD4 lymphocytes and other immune cells. We will also be studying your microbiome (the community or group of organisms or germs that live on the skin or inside the body.)

About 200 ICL patients (ages 18 and up) will take part in this study along with about 100 blood relatives and 100 household contacts of ICL subjects. Volunteers will be compensated.

Content last reviewed on January 25, 2017