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Key Researchers

Keith Henry, MD

W. Keith Henry, MD, is the Director of the HIV/AIDS Clinical Research Program. He attended Medical School at the University of Illinois, Chicago.

 

Jason Baker, MD, MS

Jason Baker, MD, MS, is an assistant professor of medicine in the division of IDIM and staff physician at HCMC. His clinical practice includes HIV medicine and inpatient general infectious disease consultation. He is conducting clinical research on cardiovascular and other common end-organ complications in persons with HIV infection, with emphasis on the mechanisms and disease risk related to vascular damage.

 

Rachel Prosser, PhDc, RN, CNP

Rachel Prosser, PhD, RN, CNP, graduated with a Bachelor of Science in Nursing from the College of Saint Benedict in Minnesota. She completed her Masters of Science in Community Health Nursing, Family Nurse Practitioner track, Certificate of International Health and Social Development and Doctorate of Philosophy in Nursing from the University of Michigan

Dr. Prosser bridges research and clinical practice with her dual duties as the research manager for the HIV/AIDS research program and a nurse practitioner in the Positive Care Center. She currently serves as a Co-investigator or Sub-investigator on various Federal and industry sponsored research protocols.

 

Suggested Links*

Positive Care Center Clinic at HCMC

American Foundation for AIDS Research

Centers for Disease Control and Prevention – HIV/AIDS

US Department of Health and Human Services – HIV/AIDS Programs

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

PBS/NOVA Online – Surviving AIDS

UNAIDS

*MMRF is not responsible for the content on external websites. The appearance of these links on the MMRF website does not constitute an endorsement by MMRF.

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Home > Our Research > HIV/AIDS

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. 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.

See Dr. Rachel Prosser discuss how research conducted at the Positive Care Center improves the lives of patients:

 

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.

— visit the Positive Care Center's clinical care site —

 

Studies Opening Soon

LATTE II Long-term injectable therapy for HIV positive persons who have not taken antiretroviral therapy (estimated May 2014)

Lactoferrin HIV Study (projected enrollment July 2014)

 

Currently Screening and Enrolling

ECSTATIN

Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV

Technology in HIV Treatment

 

Studies Closed to Enrollment

0104 Study

0109 Study

0111 Study

0112 Study

ARIES Study

Aspirin and Heart Disease Study

ASSURE Study

Cardiovascular Risk Reduction Study

ELITE Study

Gilead 103 Study

Gilead 106 Study

Gilead 110 Study

Gilead 114 Study

Gilead 115 Study

Gilead 121 Study

Gilead 130 Study

Gilead 292 102 Study

Gilead 299 102 Study

Gilead Protocol 102

GSK FLAMINGO Study

GSK LATTE Study

Medication Taking Behavior in African American Women

Pfizer MODERN Study

SAILING Study

SINGLE Study

START Study

SUN Study

SWIFT Study GILEAD AE Study

Vertex UNITE Trial

ViiV 1095 Study

 

 

All Active Studies

0104 Study — closed to enrollment
A phase three, randomized, double-blind study to evaluate the safety and efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 positive, antiretroviral treatment-naïve adults.

 

0109 Study — closed to enrollment
A phase three, open-label study to evaluate switching from a TDF-containing combination regimen to a TAF-containing combination single tablet regimen (STR) in virologically-suppressed, HIV-1 positive subjects inclusion. Patients who are virologically suppressed and enrolled in 102, 103 or 104 may participate.

 

0111 Study — closed to enrollment
A phase three, randomized, double-blind study to evaluate the safety and efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 positive, antiretroviral treatment-naïve adults.

 

0112 Study — closed to enrollment
A phase three, open-label safety study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide single-tablet regimen in HIV-1 positive patients with mild to moderate renal impairment. Basic inclusion: CD4 > 50, viral RNA >1000 eGFR 30-60.

 

ARIES Study — closed to enrollment
The ARIES 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 ARIES 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.

 

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.

 

ASSURE Study — closed to enrollment
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.

 

Cardiovascular Risk Reduction Study — closed to enrollment
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.

 

ECSTATIN — open to enrollment
Conducted in collaboration with the National Institute of Allergy and Infectious Diseases (at the National Institutes of Health). The purpose of this trial is to test the potential anti-inflammatory benefits of aspirin and atorvastatin (a cholesterol medicine) among HIV positive patients who’s viral load is “undetectable” when not taking treatment (sometimes referred to as elite controllers). Participants will have to visit the National Institutes of Health (NIH), in Bethesda, Maryland, every three months (for 15 months) where they will have all study visit procedures performed. Visits in Maryland will last 1–2 days and the NIH will pay for all study related travel, logding and food for participants during the trip.

Candidates for this study must be an elite controller, as defined by an “undetectable” viral load with no antiretroviral treatment. You must not have been on a statin or aspirin in the last six months.

To find out more about this study or to determine eligibility, please contact Andrea Dolan at 612 873 7678.

 

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.

 

Gilead Protocol 102 Study — closed to enrollment
QUAD versus 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.

 

Gilead 103 Study (GS-US-236-0103) — closed to enrollment
Gilead 103 a phase three, randomized, double-blind study designed to evaluate the safety and effectiveness of two antiretroviral regimen combinations; Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 and Ritonavir-boosted Atazanavir combined with Emtricitabine/Tenofovir Disoproxil Fumarate. A secondary goal is to determine the efficacy and tolerability of both treatment regimens based upon a 96 week period. Gilead 103 hopes to enroll approximately 700 participants that are HIV-1 positive and have never taken antiretroviral medication (with plasma HIV-1 RNA levels ≥ 5,000 copies/mL). After the designated timetable of 96 weeks is over, subjects will continue to take their designated drug and participate in visits every 12 weeks until their treatment is unblinded. After this point study subjects will have the option of participating in an another open-label rollover study to receive the EVG/FTC/TDF/GS-9350 fixed-dose combination tablet until it either becomes commercially available or Gilead Sciences decides to discontinue its development.

 

Gilead 106 Study — closed to enrollment
A phase three randomized, open-label study to evaluate switching from regimens consisting of a Ritonavir-boosted protease inhibitor and two nucleoside reverse transcriptase inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) fixed-dose regimen in virologically-suppressed, HIV-1 infected patients.

Persons may be eligible for this study if they:

To learn more about the study and if you may be eligible call Bette Bordeanve, RN at 612 873 2297 or Rachel Prosser, PhD, RN, CNP at 612 873 2877.

 

Gilead 110 Study — closed to enrollment
A Phase three-B, randomized, open-label study to evaluate the safety and efficacy of a single tablet regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate compared with a single tablet regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naïve adults.

 

Gilead 114 Study (GS-US-216-0114) — closed to enrollment
Gilead 114 is a phase three, randomized, double-blind study that is designed to evaluate the safety and effectiveness of GS-9350; which is an experimental drug which functions as a "booster" when taken with other classes of HIV drugs called protease and intergrase inhibitors. This study will explore the efficacy of GS-9350 when given in combination with Atazanavir and Truvada in reducing levels of HIV-1 in the blood of subjects who have never taken any antiretroviral medication.

The safety and effectiveness of GS-9350 will be compared with that of a similar "booster" drug called Ritonavir over a time period of 96 weeks. Gilead hopes to enroll approximately 700 participants in the 114 study with two groups of 350 subjects taking either GS-9350-boosted Atazanavir or Ritonavir-boosted Atazanavir (each administered with Emtricitabine/Tenofovir Disoproxil Fumarate). After the designated timetable of 96 weeks is over, subjects will continue to take their designated drug and participate in visits every 12 weeks until their treatment is unblinded. After this point study subjects will have the option of participating in an another open-label rollover study to receive GS-9350-boosted ATV+FTC/TDF until GS-9350 either becomes commercially available or Gilead Sciences decides to discontinue its development.

 

Gilead 115 Study — closed to enrollment
A phase three-B randomized, open-label study to evaluate switching from regimens consisting of a Ritonavir-boosted protease inhibitor (PI/r) plus Emtricitabine/Tenofovir fixed-dose combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate single-tablet regimen (EVG/COBI/FTC/TDF) in virologically-suppressed, HIV-1 infected patients please call Bette Bordenave, RN at 612 873 2297 for questions.

 

Gilead 121 Study — closed to enrollment
A phase three-B randomized, open-label study to evaluate switching from regimens consisting of a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate single-tablet regimen (EVG/COBI/FTC/TDF) in virologically-suppressed, HIV-1 infected patients please call Edie Gunderson, LPN at 612 873 2877 with questions.

 

Gilead 130 Study — closed to enrollment
A phase three-B randomized, open-label study to evaluate switching from regimens consisting of a Ritonavir-boosted protease inhibitor (PI/r) plus Emtricitabine/Tenofovir fixed-dose combination (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate single-tablet regimen (EVG/COBI/FTC/TDF) in virologically-suppressed, HIV-1 infected patients.

 

Gilead 292 102 Study — closed to enrollment
A phase two, randomized, double-blinded study of the safety and efficacy of Elvitegravir/Cobicistat/Emtricitabine/GS-7340 single tablet regimen versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate single tablet regimen in HIV-1 infected, antiretroviral treatment-naïve adults. Please call Edie Gunderson, LPN at 612 873 2877 with questions.

 

Gilead 299 102 Study — closed to enrollment
A phase two, randomized, double-blinded study of the safety and efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 single tablet regimen versus Cobicistat-boosted Darunavir plus Emtricitabine/Tenofovir Disoproxil Fumarate fixed dose combination in HIV-1 infected, antiretroviral treatment-naïve adults.

 

GSK FLAMINGO Study — closed to enrollment
A phase three-B, randomized, open-label study of the safety and efficacy of GSK1349572 (Dolutegravir, DTG) 50mg once daily compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects. Please call Bette Bordenave, RN at 612 873 2297 with questions.

 

GSK LATTE Study — closed to enrollment
A phase two-B, dose ranging study of oral GSK1265744 in combination with nucleoside reverse transcriptase inhibitors for induction of HIV-1 virologic suppression followed by an evaluation of maintenance of virologic suppression when oral GSK1265744 is combined with oral Rilpivirine in HIV-1 infected, antiretroviral therapy naïve adult subjects.

 

Lactoferrin HIV Study — projected enrollment July 2014
The purpose of this study is to test the tolerability and potential benefits of Lactoferrin, a natural protein made by the body which may have immunologic benefits that reduce inflammation. “Inflammation” represents ongoing activation of the body’s immune system that can cause damage to the heart and other organs over time. Heart disease from ongoing inflammation in the body is now a leading health concern for individuals with HIV infection receiving effective treatment with antiretroviral therapy (ART). The study will last approximately seven months, and include six study visits in which cash compensation is provided. Each visit will include a brief exam, medical history, blood draw and vitals.

The following criteria must be met to be considered for participation:

To learn more about this study or to determine eligibility, please contact Andrea Dolan at 612 873 7678.

 

Pfizer MODERN Study — closed to enrollment
A multicenter, randomized, double-blind, comparative trial of Maraviroc + Darunavir/Ritonavir versus Emtricitabine/Tenofovir + Darunavir/Ritonavir for the treatment of antiretroviral-naïve HIV-infected patients with CCR5-Tropic HIV-1. Please call Bette Bordenave, RN at 612 873 2297 with questions.

 

A Reasonable Approach to Examining Medication Taking Behavior in African American Women — closed to enrollment
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 Prosser, the Positive Care Center Research Manager/Nurse Practitioner, at 612 873 2877.

 

Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV — open to enrollment
Conducted in collaboration with the U of MN. The purpose of this study is to find out if an FDA approved medication (losartan), which is not currently used to treat HIV infection, can reduce damage within immune tissue (e.g. lymph nodes) among individuals with HIV infection. If established, this treatment could be used to improve immune function beyond what currently occurs with HIV antiretroviral therapy. The study lasts 2.5 years. Research visit procedures include blood draws and periodic lymph node biopsies (three times) and colonoscopies (three times), in which cash compensation is provided.

The following criteria must be met to be considered for participation:

To learn more about this study or to determine eligibility, please contact Kristin Grunewaldt at 612 873 2905 or Andrea Dolan at 612 873 7678.

 

SAILING Study — closed to enrollment
A phase three randomized, double-blind study of the safety and efficacy of GSK1349572 50 mg once daily versus Raltegravir 400 mg twice daily, both administered with an investigator-selected background regimen over 48 weeks in HIV-1 infected, integrase inhibitor-naïve, antiretroviral therapy-experienced adults.

SAILING is a study for persons who have taken HIV medication and have documented HIV drug resistance. For more information about when the study will be opened or inclusion/exclusion criteria, call Bette Bordeanve, RN at 612 873 2297 or Rachel Prosser, PhD, RN, CNP at 612 873 2877.

 

SINGLE Study — closed to enrollment
A phase three, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects.

SINGLE is a study for persons living with HIV, who have never taken HIV medications and are interested in starting HIV medications. For more information about when the study will be opened or inclusion/exclusion criteria, call Edie Gunderson, LPN at 612 873 7678 or Rachel Prosser, PhD, RN, CNP at 612 873 2877.

 

START Study — closed to enrollment
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.

 

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.

 

SWIFT and GILEAD AE Studies — closed to enrollment
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.

 

Technology in HIV Treatment — open to enrollment
The University of Minnesota and HCMC Positive Care Center are recruiting men with HIV to participate in a focus group about their use of technology. The focus group will last about 1 1/2 hours and food will be served. Men who qualify for the study and complete the focus group will receive a gift certificate for their participation. Take the pre-screening survey to determine eligibility and get more information about the study.


Vertex UNITE Trial — closed to enrollment
An open-label, phase three study of Telaprevir in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in subjects coinfected with genotype 1 hepatitis C virus and human immunodeficiency virus type 1(HCV/HIV-1). Please call Bette Bordenave, RN, at 612 873 2297 with questions.

 

ViiV 1095 Study — closed to enrollment
A multicenter, randomized, double-blind, comparative trial of Maraviroc + Darunavir/Ritonavir versus Emtricitabine/Tenofovir + Darunavir/Ritonavir for the treatment of antiretroviral naive HIV-infected patients with CCR5-tropic HIV-1.