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HIV and Emerging Infectious Diseases Program

HIV 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:

A Phase 1 Study of CC-11050 in Human Immunodeficiency Virus-1-Infected Adults with Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE)

(APHRODITE – Protocol # 16-I-0044)

NIH is conducting a research study to determine if an experimental drug is safe for people with HIV infection who are taking HIV medications. The drug is designed to prevent and treat inflammation. We would like to develop a treatment to reduce inflammation in HIV-infected people in order to prevent problems like cardiovascular disease (such as stroke or heart attacks), liver and kidney disease, and bone loss. The inflammation-reducing drug we are testing in this study is called CC-11050. It is made by a company called Celgene Corporation. CC-11050 has not been approved by the Food and Drug Administration (FDA) because it is still being studied in research trials. CC-11050 has been studied in healthy people and in people with a disease of the immune system called lupus, but has not been studied in people with HIV. Throughout the duration of the study you will continue to take your HIV medications as before. You will be seen at NIH about seven times in a six- month period. Volunteers will be compensated.

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.

Cardiometabolic Effects of Eplerenone in HIV Infection

(ECHO – Protocol # 16-I-0030) 

The NIH is conducting a research study for people with HIV infection who are taking HIV medications.  People with HIV are at a high risk of developing visceral or “deep” belly fat compared to people without HIV. Visceral fat can lead to health problems like inflammation, heart disease, diabetes, and a type of liver disease called steatohepatitis.

​Research studies suggest that blocking a hormone called aldosterone might work to help reduce the health consequences associated with increased belly fat. In 2002, the US Food and Drug Administration (FDA) approved a drug called eplerenone (trade name Inspra) to treat high blood pressure. Eplerenone works by blocking aldosterone from communicating with the body. The main purpose of this research study is to test if eplerenone will reduce the amount of fat stored in heart muscle and liver in people with HIV and increased visceral fat. We plan to test eplerenone in 20 people with HIV.  Volunteers will 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.

Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV (LIFE-HIV) Trial

(LIFE-HIV – Protocol #14-CC-0179)

NIH is conducting a research study of a medication called losartan (or COZAAR). This study may provide information that will improve the health of HIV-positive people who are already on HIV medicines. Losartan is approved by the Food and Drug Administration (FDA), but not for treatment of HIV infection; it is commonly used to treat high blood pressure. Use of losartan in this study is investigational. However, we think this medication may help address some of the damage that HIV causes in the body.

Damage caused by HIV infection results in problems with the immune system. These problems cannot be fully corrected, even with effective treatment using antiretroviral medications. One of these problems is inflammation. "Inflammation" occurs when the body’s immune system responds to injury or infection. Inflammation can be helpful in the short term, but when it is persistent it can also cause more damage to the body over time. HIV also damages the immune system by causing scarring in tissues such as lymph nodes. This scarring limits recovery of the immune system after treatment with antiretroviral therapy is started.

A total of 100 individuals are expected to participate in this study; we expect to enroll 20 at NIH. Individuals are being recruited at four different clinical sites in the United States. Volunteers will be compensated.

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.

Effect of Early Antiretroviral Therapy on Maintenance of Immune Cell Function

(RPHI – Protocol #02-I-0202)

This study is recruiting volunteers either at the Acute (early signs and symptoms of HIV infection and/or less than four months of known HIV exposure) and Chronic stage (greater than six months or determinate positive result) of infection and who have elected to begin HAART (provided by participant's Primary Care Provider). The study will require that patients be apheresed once before antiretroviral therapy and several times after suppression of plasma viremia (less than 50). Travel assistance will be provided (for non-local volunteers). Participants will be reimbursed for their time and inconvenience.

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-CC-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.

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Last Updated August 01, 2016