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:


HIV Studies

2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults with Features of the Metabolic Syndrome

(2-5toWin– Protocol #18-I-0075)

The NIH is conducting a research study for people living with HIV and on HIV medications. The purpose of this research study is to see if intermittent caloric restriction (ICR) leads to weight loss and improved blood sugar in obese people infected with human immunodeficiency virus (HIV). We want to find out if ICR is an effective alternative to traditional diets.

All participants will receive standard counselling on a healthy diet and lifestyle. Subjects will then be randomly assigned (like a flip of a coin) to either a 12-week ICR diet plan or the 12-week standard diet. All individuals in both study groups will receive American Heart Association dietary counseling, lifestyle and physical activity counseling, and a pedometer to measure daily steps and instructions for use. Subjects who enter the study will complete 8-10 study visits over a period of approximately 7 months.

A total of 50 individuals between the ages of 18-65 are expected to participate in this study. Volunteers will be compensated.

Comprehensive Evaluation of the Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals

(ATI– Protocol #17-I-0106)

The NIH is conducting a research study for people living with HIV and on HIV medications.  In most people infected with HIV, their immune system is not able to control HIV infection and daily medications are needed. Combination antiretroviral therapy (cART) is a combination of anti-HIV drugs taken daily in order to keep the amount of HIV virus very low for a long time and prevent HIV infection from damaging the immune system.

The main purpose of this study is to gain more information on the impact of a short-term treatment stop on HIV, which persists even while taking cART. Understanding why HIV replication continues could provide an explanation of the source of the HIV persistence. When stopping treatment, the information gathered could show the study team how to develop curative treatments in the future.

A total of 30 individuals between the ages of 18-65 are expected to participate in this study.  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.

Herpesviruses Reactivation in HIV-Infected Women Initiating ART (HERA)

(HERA – Protocol #17-I-0072)

The NIH is conducting a research study about the effects of HIV treatment in women who may have herpes virus infections. Herpes virus can cause sores on the vagina, around the mouth, or on the skin. It can also cause flu-like symptoms such as fever and muscle aches. Another type of herpes virus can cause shingles or chickenpox, and another type can cause Kaposi sarcoma, a type of cancer that can affect the skin or other body organs like the mouth, gut, or lungs. Herpes viruses do not always cause symptoms, so people with herpes virus infection may not know that they have it. 

Many people with HIV also have infections with herpes virus. When these people start taking HIV medicines, their herpes virus symptoms can suddenly start or become worse. We are inviting you to participate in this study so that we can look at how often this happens and why. In this study, we will measure herpes infection in women who are starting HIV treatment. The medicine used to treat HIV is called "antiretroviral therapy," or "ART" for short. The ART medications we are using on this study are approved by the U.S. Food and Drug Administration for HIV treatment. We will study changes that happen in the body when a person starts ART and how those changes may make herpes virus symptoms worse. 

The study will last about one year.  We will enroll about 200 women on this study. This study will take place at the NIH and at a health clinic in Uganda.

ART will be provided while on study only, and 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.

A Randomized, Double-Blind, Placebo-Controlled Study of a Single Dose of Pembrolizumab in HIV- infected Patients

(PIPPIN– Protocol #18-CC-0013)

The NIH is conducting a research study for people living with HIV and on HIV medications whose CD4 t-cell count is >100 but <350, with an undetectable HIV viral load.  The purpose of this research study is to see if a drug called pembrolizumab is safe to use in people with HIV, and if it strengthens the immune system. Pembrolizumab is considered an experimental treatment in this study because it is not approved by the Food and Drug Administration (FDA) for treating HIV infection. This means that we don't know whether pembrolizumab is safe to use in HIV-infected people or whether it will work to treat your HIV infection. Pembrolizumab is made by the drug company Merck and sold under the name Keytruda. The FDA has approved it for treating different types of cancers including lung cancer and skin cancer. The FDA has given us permission to use it in this study. This is among the earliest studies of pembrolizumab in people who have HIV infection but do not have cancer. 

One group will get the study drug, and the other group will get a "placebo." A placebo looks just like the study drug but does not have any active drug in it. Researchers use a placebo to see if the study drug is more or less safe or effective than not taking anything. Whether you get the study drug or placebo will be decided randomly. This is like deciding by flipping a coin. Overall, 15 people will get the study drug and 5 will get the placebo. Neither you nor the study team will know which group you are in, but in the case of an emergency, we can find out. 

A total of 20 individuals 18 years old and older are expected to participate in this study.  Volunteers will be compensated.

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. ​

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

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.


Healthy Volunteer Studies

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.

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

(YODA – Protocol #18-CC-0087)

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: rifapentine and isoniazid.

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.


Idiopathic CD4 Lymphocytopenia (ICL) studies

A phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus recombinant vaccine in patients with idiopathic CD4 T cell lymphocytopenia

(APOLLO – Protocol #18-I-0092)

We are studying the effects of GARDASIL 9 vaccination in people with ICL, which stands for idiopathic CD4 T cell lymphocytopenia. People with ICL get more human papillomavirus (HPV)-related diseases than people without ICL. HPV-related diseases include skin and genital warts and a variety of genital and anal precancerous lesions and cancers. These diseases are also more severe and harder to treat in people with ICL.

We expect a total of 65 people to participate in this study, both with and without ICL.  We will use the information that we get from this study to learn more about how people with ICL respond to HPV infection and vaccination. We also hope that what we learn will help in the development of new treatments in the future. Volunteers will be compensated.

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.

A phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus recombinant vaccine in patients with idiopathic CD4 T cell lymphocytopenia

Content last reviewed on May 16, 2018