HIV / AIDS Research at HCMC's Positive Care Center
Dr. Keith Henry, Research Director of HCMC HIV/AIDS Program collaborates with and is supported by Dr. Ronald Schut the HCMC HIV/AIDS Program Director. The HIV/AIDS team unites to improve the care of persons living with HIV. The HCMC HIV/AIDS program sees more HIV infected patients than any other clinic in Minnesota.
While Dr. Keith Henry is studying new drugs, strategies and searching for answers to this devastating disease, his goal is that every HIV infected person live a quality life.
Dr. Henry's expansive experience and cutting edge style in research provides patients with opportunities to enroll in clinical trials. These trials often allow the participants access to the newest therapies that are available only in a research setting. There are drugs "in the pipeline" that don't yet have FDA approval, but look very promising that can be offered to study participants through clinical trials.
Current Research
The HIV/AIDS Research Program is a Minneapolis Medical Research Foundation (MMRF) designated research program. MMRF HIV/AIDS research supports and collaborates with numerous local and national organizations to study the most applicable, pertinent and cutting edge drugs, strategies and therapies. For more information on the following studies, please contact Bette Bordenave, 612 873 2297 or Edie Gunderson, 612 873 7678.
SWIFT Study GILEAD AE Study - SWIFT closed to enrollment, GILEAD AE open
Cardiovascular Risk Reduction Study
Medication Taking Behavior in African American Women
Gilead Protocol 0102 - closed to enrollment
SUN Study - closed to enrollment
ELITE Study - closed to enrollment
Aspirin and Heart Disease Study - closed to enrollment
ARIES Study - closed to enrollment
THRIVE Study - closed to enrollment
ASSURE Study
A study of Reyataz, Epzicom, Truvada and Norvir in Adults living with HIV. A "switch study." People who are stable on Truvada, Reyataz and Norvir may or may not be switched to Epzicom and Reyataz. The study is 48 weeks and provides eligible participants with medications, labs, study tests and cash compensation at the completion of each study visit. To learn more call Bette Bordeanve, RN at 612 873 2297.
START Study
Strategic Timing of AntiRetroviral Treatment (START) is a multi-site, international study that will be carried out in two phases; a pilot and definitive phase. The pilot phase aims to enroll 900 participants in the first year. The definitive phase aims to enroll up to 4,000 participants. START will examine the benefits of beginning antiretroviral treatment early against the risks of side effects and drug resistance. Participants will be randomized to one of two groups; 1) starting antiretroviral therapy (ART) when the CD4 cell count is greater than 500 mm3 OR 2) starting ART when the CD4 cell count is below 350 mm3. Currently, ART is clinically indicated when the CD4 cell count is lower than 350 mm3. Results from START will help inform future HIV treatment guidelines. Participants will receive ART at no cost.
SWIFT and GILEAD AE Studies - SWIFT closed to enrollment, GILEAD AE open
Some HIV medications may influence risk for heart disease, but the effect may be quite different for different HIV medications. Several research studies have attempted to answer the question, “Is abacavir use related to increased risk for heart disease?” Despite several studies examining the relationship between abacavir and heart disease, the question is unanswered. The SWIFT and Gilead AE studies are looking at whether markers for heart disease change if persons taking abacavir change to another, very similar, HIV medication. Patients that are currently taking abacavir and lamivudine (co-formulated as 'Epzicom') and have a 'suppressed viral load' may be eligible to participate in these studies. Participants will either continue to take 'Epzicom' or will switch to a medication called 'Truvada' (tenofovir DF and emtricitabine), and will complete five, approximately 60 minute, study visits over one year. Participants will be compensated in cash for their time and travel expenses.
Cardiovascular Risk Reduction Study
This study is funded by the American Heart Association. The goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with HIV infection. Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such is the case with HIV infection).
Participants who are taking HIV treatment with an ‘undetectable’ viral load, and who do NOT need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at three study visits over four months. A monetary stipend will be provided to compensate participant’s time at study visits.
A Reasonable Approach to Examining Medication Taking Behavior in African American Women
African American women living with HIV… taking medicine is hard. Lots of people miss doses. The goal of this study is learn more about the lives of African American women living with HIV to better understand how to help.
If you are an African American women living with HIV, taking at least one antiretroviral agent and between the ages of 18-60, you may be eligible to participate.
You will be asked to complete a memory test and answer some questions about HIV, taking medicine, spirituality, how you feel, and your relationships with other people. The study visit will take less than one hour. You will be given $20 after answering questions during the study visit.
If you are interested, please call Rachel, the Positive Care Center Research Manager/Nurse Practitioner, at 612 873 2877.
Gilead Protocol 0102 - Closed to enrollment
QUAD vs Atripla. This study is for persons who have never taken an HIV drug before and are ready to start HIV medications. Participants would be randomized to either starting the QUAD drug (one pill once a day) or Atripla (one pill once a day). Study will provide drugs, labs and cash compensation for at least two years.
The SUN Study - Closed to enrollment
Study to Understand the Natural History of HIV and AIDS. Primary objective of this study is to determine the occurrence and risk factors for non-AIDS defining conditions in HIV-infected patients who are receiving regular HIV and other medical care. The SUN Study will be evaluating HIV primary prevention through screening; treatment and counseling about STDs and HIV risk behaviors. At least 500 participants who are relatively early or mid-point in the course of their HIV infection and treatment will be monitored by various tests. Regular Dexa scanning for bone and fat problems, initial cardiovascular, renal, liver and other tests will be utilized in managing participants care.
ELITE Study – Closed to enrollment
After being infected with HIV, most persons experience progression of HIV. However, few (approximately 1% - 2% of persons infected with HIV) persons maintain HIV viral loads below the limits of detection without antiretroviral medications. The HIV Controller Consortium proposes to perform detailed genetic testing in the small subset of persons who maintain undetectable HIV viral loads without antiviral therapy. Through a nationwide collaborative effort with academic institutions and primary care physicians, a cohort of 180 persons that we call “HIV controllers” (persons who maintain undetectable HIV viral loads without ever receiving antiretroviral therapy) will be established. The primary goal of this study is to gain a better understanding of the spontaneous control of HIV replication using human genetic tests. The Elite Study will provide a unique opportunity to determine the extent to which persistent control of the HIV virus is possible. Understanding the reasons why some individuals are able to maintain such control is a critical issue, since the first generation of an AIDS vaccine would be considered a success if it were able to create such a state of control following an exposure to HIV.
Aspirin and Heart Disease Study - Closed to enrollment
Research has shown that persons with HIV infection are at increased risk for heart disease. This study is looking at inflammation and damage to blood vessels that occurs before patients have symptoms of heart disease. Participants who are not currently taking HIV treatment (‘antiretrovirals’) but plan to start (or resume) treatment may be eligible to enroll. Participants and their HIV doctor will determine which specific HIV drugs will be started. Participants will then take either aspirin or a placebo pill, and be seen at four - five study visits (about one hour each) over five - six months. A monetary stipend will be provided to compensate participant’s time at study visits.
ARIES Study - Closed to enrollment
The Aires study is a randomized, open-label, multi-center study that aims to explore the safety and efficacy of an initial regimen that includes highly active antiretroviral therapies (HAART) and a protease inhibitor. Combination antiretroviral therapy regimens for the treatment of HIV infection have been shown to result in durable and substantial viral load reductions that can delay the progression of HIV and prolong survival. The primary objective of the Aires study is to evaluate the efficacy, safety, tolerability and durability of the antiviral response between Atazanavir (ATV) + Ritonavir (RTV) and a fixed dose of Abacavir sulfate for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV+RTV for an additional 48 weeks each in combination with the Abacavir sulfate. New drugs and clinical data necessitate ongoing evaluation of the best treatment choices since ART regimen selection remains a dynamic process.
THRIVE Study - Closed to enrollment
THRIVE is a 96-week, randomized, controlled, double-blind phase III clinical trial to assess and compare the efficacy, safety and tolerability of TMC278 and Efavirenz (EFV), each in combination with a background regimen. Approximately 680 HIV-1 infected, treatment naive participants have been randomized to receive TMC278 or EFV and the background regimen their HIV provider chooses. The trial is comprised of a six week screening period, a 96 week treatment period followed by a four week follow up period. The primary objective of this study is to demonstrate the non inferiority of TMC278 versus EFV with regard to the proportion of subjects achieving a decreased plasma viral load. In addition, the efficacy, the safety, tolerability, durability of antiviral activity, immunologic changes, pharmacokinetics, patient reported outcomes and medical resource utilization will be assessed throughout the trial.
