Clinical Studies

Information for patients with HIV infection who are interested in clinical trials.

Seattle Cancer Care Alliance

defeatHIV clinical studies are performed in Seattle, WA at the Seattle Cancer Care Alliance (SCCA). The SCCA is the treatment arm of the world-renowned Fred Hutchinson Cancer Research Center, and operates the largest bone marrow transplant program in the world.

Currently patients with HIV infection have many options for therapy. Most importantly, highly active anti-retroviral therapy (HAART) is used to stop the virus from reproducing itself and from causing harm. In most people, HAART prevents progression of HIV infection and allows people to return to normal life. However, HAART does not cure HIV infection because the virus is able to survive in a dormant state (called the latent HIV reservoir). In fact, when HAART is stopped, the HIV virus usually grows back within a couple months, to the same level as in the beginning of the infection.

People living with HIV may develop blood cancers such as leukemia, just as those without HIV develop. HIV infection also may increase a person’s susceptibility to developing lymphoma. Whether or not a person has HIV, lymphomas and leukemias are treated the same way, usually with powerful chemotherapy drugs. Sometimes, a hematopoietic cell transplant (HCT) is the best treatment, especially for treatment of a relapse. In the past, HCT was not recommended for patients living with HIV, because very intensive drugs were given that caused harmful effects to the body and made it easier for the HIV to grow. Since that time there has been progress in several areas that now make it much more likely that HCT will be successful in people living with HIV.

The first is the ability to give HAART after HCT, which helps to keep the HIV under control. Controlling the HIV is very important for patients who need intensive chemotherapy or radiation as part of the HCT, such as patients with lymphoma or advanced leukemia.

The second is the potential for HCT to cure HIV if “HIV-resistant cells” are given back to the patient. We know this is possible because one patient treated in Berlin (known as the “Berlin patient”) received cells from a donor who carried a rare, natural mutation that created resistance to HIV. The patient no longer needed HAART after he recovered from the HCT, and the virus did not grow back.

Third, is the development of a new and potentially safer transplant procedure that requires less powerful agents to prepare the body for transplantation. This procedure was developed at the Fred Hutchinson Cancer Research Center and has been studied here and in several other institutions. We have used this procedure successfully in patients with immunodeficiency diseases not caused by HIV and in older cancer patients. Thus far the results have been encouraging and show a lower risk of severe side effects or death resulting from the transplant procedure compared to traditional transplant procedures.

Why are we doing research in HCT and cell therapies for patients with HIV?
There is a lot of potential for HCT and other cell therapies, such as gene therapy, to help patients living with HIV. There also is a need for information about the responses of patients to cell therapies, so that we can make the procedures as safe as possible. And, because of the success of the “Berlin patient”, there is a need to understand how HCT was able to get rid of the latent HIV reservoir. We hope that by answering these questions we will learn how to defeatHIV.

What clinical studies are available for patients living with HIV?
Several clinical studies are open for patients living with HIV. This section will provide a brief outline of each study and the eligibility criteria.