To learn about all of NIAID’s HIV clinical studies and how to join these trials see the HIV Clinic Studies page.
The Partnership for Access to Clinical Trials (PACT) team is available to answer questions and facilitate entry into the following priority protocols:
(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.
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.
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-I0075)
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.
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.
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.
(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.