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:
(bNAb – Protocol #15-I-0140)
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 experimental product called “VRC01” is safe and if it can control the amount of HIV in your blood when you are not taking your cART. “Experimental” means that the study product is not approved by the Food and Drug Administration (FDA). This means we don’t know whether VRC01 is safe to use in people or whether it will work to treat your HIV infection. Use of this study product, VRC01, is permitted for research studies only. The way we will see if the VRC01 works is by checking the levels of HIV; CD4 cells (the "good" immune cells that are damaged by HIV); and other measures of HIV infection after you receive this product and have stopped taking your cART.
A total of 30 individuals between the ages of 18 and 65 are expected to participate in this study. To be in the study, you must be willing to stop your HIV medications for at least 24 weeks and to practice safer sex. Volunteers will be compensated.
(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.
(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.
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.
(GUTCHEK – Protocol #13-I-0062)
You are being invited to participate in this research study because you are HIV-infected and are taking medications (antiretroviral therapy [ART]) for treating this infection. HIV treatment can control HIV, but therapy does not provide a cure. The reasons why therapy does not cure HIV infection are not well understood. HIV persists in blood cells for years, even while people are taking ART. In addition, HIV infection leads to an activated immune system, which can contribute to persistence. Immune activation improves, but does not fully resolve with ART. A better understanding of HIV and the immune activation HIV causes will help understand HIV persistence and identify new strategies to eliminate HIV infection.
In this study, we are investigating the source of immune activation in HIV infection. In general, chronic immune activation may be thought of as an exaggerated response to infection. It is not clear why HIV-infected patients have this exaggerated response. One theory why HIV infection causes immune activation has to do with the gastrointestinal tract. HIV infects immune cells the intestine (gut) soon after infection and causes damage to the intestinal immune barrier. The damage to the intestine lets bacterial products cross into the blood stream, leading to ongoing inflammation. Even when a person with HIV feels well, this chronic leakage of bacterial products may affect the immune system. In this study, we are planning to investigate whether taking Rifaximin, an antibiotic used to reduce bacteria in the intestine, will reduce leaking of bacterial products into the blood stream. Rifaximin is taken by mouth and is designed to stay inside the digestive system, so it's effects on bacteria are only within the intestines. Volunteers will be compensated.
(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.
(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.
(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.
(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.
(TAF– Protocol #15-I-0201)
The NIH is conducting a research study of a different form of tenofovir (TDF) that may work with people whose HIV is resistant to TDF; it also may be less damaging to kidneys. This new ART drug is called tenofovir alafenamide, or TAF. It is made by a drug company called Gilead Sciences. Currently, TAF is being studied in research trials for people with HIV or hepatitis B virus (HBV) infection. For this study, the Food and Drug Administration (FDA) has allowed us to provide TAF in a combination pill with another ART drug called emtricitabine to people whose HIV infection cannot be successfully treated with other ART drugs. Emtricitabine has been approved by the FDA and is widely used for treating HIV infection. The combination pill is also called F/TAF.
We are inviting up to 20 volunteers to participate in this study. In addition to F/TAF, you will be prescribed other ART drugs that are FDA-approved. These drugs will be prescribed to you under the “DOTCOM” study (14-I-0009), which also takes place in our clinic. (The DOTCOM study information is also on this web site.) We will evaluate your response to this ART combination and watch for side effects. If F/TAF works well for you, we will do our best to continue providing this drug to you until it is approved by the FDA and available in pharmacies. No additional compensation will be provided.
(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.
(THERAVAX – Protocol #13-I-0141)
NIH is conducting a research study to see how well people with HIV tolerate “therapeutic vaccination.” In most people infected with HIV, their immune system (the body’s normal ability to fight off disease) 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. Also, cART doesn’t completely remove HIV from your body.
Therapeutic vaccination means giving a vaccine to TREAT an infection that someone already has (HIV in this case). Normally, we give vaccines to PREVENT a person from getting infections (for example, there are vaccines to prevent the flu and the measles).
We also want to see how levels of HIV, CD4 cells (the ‘good’ immune cells that are damaged by HIV), and other measures of HIV infection change after a person receives this vaccination. We plan to show this by stopping cART after some people have been given therapeutic vaccination and others have been given a placebo (a salt water-like solution that should have no effect), for comparison. Volunteers will be compensated.
(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 November 16, 2015