Experienced Studies


Below are the experienced studies that the ACTU is currently involved in. Click on the links to learn more about each of these studies.


A5258

A5258 is a randomized, double-blind, placebo controlled study to evaluate the use of chloroquine in chronically infected patients who are not receiving antiretroviral therapy (ART). The purpose of this study is to learn how well chloroquine, an FDA approved medication used to treat malaria, reduces the level of activated CD8 T cells. Increased activation of CD8 T cells has been associated with progression of HIV disease.

Inclusion Criteria:

  • HIV infected male or female between the ages of 18 and 65.
  • CD4+ count of 400 or greater.
  • HIV viral load of 20,000 or greater.

Exclusion Criteria:

  • Pregnant or breast-feeding.
  • Taken ART within 6 months of going on study, or likely to start within 6 months of going on study.

For more information contact Sara Powell at (513)584-6617.


A5281

A Phase I Randomized, Partially Double-Blind, Placebo-Controlled, Dose-Escalation study to Evaluate the Safety and Immunogenicity of a Cytokine Enhanced HIV-1 Multi-Antigen (HIV MAG) pDNA Vaccine Delivered Intramuscularly Followed by in Vivo Electroporation (IM/EP) or Intramuscularly in HIV-1 Infected Adults Receiving ART.

Inclusion Criteria:

  • HIV positive and 18 to 55 years of age.
  • Stable ART for a minimum of 6 months.
  • CD4+ count > 500 cells/cumm.
  • HIV viral load < 50 copies/mL.
  • Hepatitis B surface antigen negative.
  • Hepatitis C antibody negative, or if HCV antibody positive, HCV RNA negative.
  • Negative pregnancy test. Must adhere to contraception.

Exclusion Criteria:

  • CD4+ count < 200 cells/cumm at any time.
  • Active malignancy requiring chemotherapy or radiation therapy.
  • Bleeding diathesis or any condition associated with prolonged bleeding that would contraindicate IM injection.
  • Use of immunomodulatory, cytokine, or growth stimulating factors within 30 days prior to study entry.
  • Pregnancy or currently breastfeeding.
  • Use of any prior HIV vaccine (prophylactic and/or therapeutic) within 1 year prior to study entry.
  • Use of any investigational treatment within 6 months prior to study entry.
  • Any licensed or experimental non-HIV vaccination within 4 weeks prior to study entry.
  • Use of infusion blood product or immune blobulin within 3 months prior to study entry.

For more information contact Sara Powell at (513)584-6617.


A5275

A Pilot Study Evaluating the Effect of Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis, and T-lymphocyte Activation in HIV-1 Infected Individuals with Suppressed HIV-1 RNA and LDL Cholesterol < 130 mg/dL.

Inclusion Criteria:

  • Currently on ART therapy which includes a boosted PI regimen for at least 6 months prior to study entry.
  • On same HAART regimen for at least 12 weeks and no plans to change within next year.
  • If on vitamin D replacement, must be on stable regimen for at least 1 month prior to study entry.
  • VL < 40 copies within 45 days prior to study entry; all VL tests within 180 days are below limit of detection.
  • Adherence to birth control.

Exclusion Criteria:

  • Current or past malignancy (except non-melanoma cancer of the skin).
  • Known cirrhosis.
  • Chronic active hepatitis B or C.
  • Coronary artery disease (CAD) or CAD equivalent including diabetes mellitus or CHD risk of >20%.
  • Known inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease, chronic pancreatitis, autoimmune hepatitis, myositis, or myopathy.
  • Pregnancy or breastfeeding.
  • Previous intolerance to statins.
  • Use of immunosuppressants, lipid-lowering therapies, systemic antineoplastic or immunomodulatory agents, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin.
  • Coagulopathy, deep vein thrombosis, or pulmonary embolism.
  • History of recurrent rectal and/or genital herpes simplex virus (HSV) or varicella zoster virus (VZV).
  • History of stroke.

For more information contact Jenny Baer at (513)584-8022, Eva Moore at (513)584-4819 or Sara Powell at (513)584-6617.

A5293

Effect of HDL-Raising Therapies on Endothelial Function, Lipoproteins, and Inflammation in HIV-infected Subjects with Low HDL Cholesterol: A Phase II Randomized Trial of Extended-Release Niacin vs. Fenofibrate

Brief Description:

A5293 is a study for HIV-infected people who have low levels of high-density lipoprotein cholesterol (HDL-C) and elevated triglycerides. This study will randomize participants to receive an HDL-C raising medication, either extended-release niacin or fenofibrate, for 24 weeks.

Objectives:

The main purpose of this study is to see if taking either extended-release niacin or fenofibrate will help blood vessels work better by improving endothelial function and increasing HDL cholesterol. Cholesterol is a soft, waxy substance found in all parts of the body, and triglycerides are a type of fat in your blood. HDL-C is a type of “good” cholesterol. People with low HDL-C have a higher risk of heart disease and may have problems with how their blood vessels relax. “Endothelial function” refers to how well the endothelium, the inner lining of blood vessels, is working. When your endothelium is not working properly, the blood vessels have trouble expanding properly, which contributes to the development of heart and blood vessel disease. This study will also help determine how safe extended-release niacin and fenofibrate are.

Inclusion Criteria:

  • HIV-1 infected men and women age = 18 years
  • Currently on anti-HIV medications for =48 weeks
  • HIV viral load level “undetectable”
  • CD4+ cell count =100
  • HDL-Cholesterol = 40 mg/dL for men or = 50 mg/dL for women
  • Fasting triglycerides 200-800 mg/dL
  • LDL-Cholesterol < 160 mg/dL
  • Not currently taking lipid-lowering agents, and not planning to start
  • Not on high dose of fish oil (i.e., doses above 1000 mg daily), niacin, Vitamin E or C
  • No history of heart disease, diabetes, or untreated hypertension

For more information contact Jenny Baer at (513)584-8022, Eva Moore at (513)584-4819 or Sara Powell at (513)584-6617.


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