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Research

Types of Studies at the ACTU


We offer the following types of studies:

Screening Study

Cohort

This is a study for those interested in learning more about the studies offered at the AIDS Clinical Trials Unit. The study provides free lab tests; which include CD4 counts and HIV viral load and automatic access to clinical trials for HIV infected persons interested in research participation.

Studies for those who have never taken anti-HIV medicines:

ACTG 5303: is a 48-week study for people who are infected with the R5 type of HIV virus and have never taken HIV medications. Participants will receive an experimental regimen darunavir (Prezista®)/ ritonavir (Norvir®) + maraviroc (Selzentry®) + emtricitabine (Emtriva®) once-daily or a standard regimen durunavir/ritonavir + tenofovir (Viread®) + emtricitabine once-daily for 48 weeks.   The main purpose of the study is to compare the effects of the regimens on bone mineral density (BMD) as measured by a DXA bone scan in patients who have never taken HIV medications (a DXA scan is a special kind of x-ray using a small amount of radiation, allowing the doctor to see parts of the body better than a regular x-ray).  To be eligible for this study, you must have not taken anti-HIV medications and have an HIV viral load greater than 1,000.   All study medications are provided for the duration of the study.

ACTG 5308: This 60-108 week study is being done with people who are infected with HIV, but do not show any signs of having HIV, and are doing well without taking HIV medication. The purpose of this study is to see if taking HIV medication (antiretroviral therapy [ART]) will reduce immune activation (the body’s way of fighting disease) in people who have HIV, but do not show symptoms. This constant immune activation may be harmful and lead to premature aging or conditions such as heart disease. Also this study will help determine how safe the drug is and how well the body reacts to the drug. Volunteers must be 18 years of age or older and have an HIV-1 viral load of less than 500 copies for a period of at least 24 months. Volunteers cannot have taken antiretroviral (anti-HIV) medications in the past. Participants will be provided Complera during the study.

START

This study is being done to see when is the best time to START taking anti-HIV medications; either when the CD4 cell count is high or wait until it decreases. All participants are randomly assigned into one of two groups:
1). START anti-HIV medications immediately or 2). Wait to START until the CD4 cell count is <350.  To be eligible for START, participants must have a CD4 T-cell count of more than 500, and have not yet taken HIV medications. All study-related costs and medications are provided throughout the study.  All START participants stay in their assigned groups for the duration of the study, which is expected to be about 5 years.

MACS

The Multicenter AIDS Cohort Study (MACS) is an ongoing prospective study of the natural and treated HIV infection in men who have sex with men.  Visits will be twice a year and to be eligible for this study you must have never taken anti-HIV medications and have or had sex with men.  Subjects will be in this study until 2014.

WAVES (for women only)

The purpose of this study is to see if the combination pill Stribild™ is safe and effective in reducing levels of HIV in the blood of female subjects who are treatment-naïve (those who have not received any antiretroviral medication).  Participants must be female and age 18 or older, have a HIV viral load >500, not pregnant, and never taken antiretroviral therapy.  Volunteers will be randomized to take Stribild or atazanavir/ritonavir and Truvada.  Participants will be in this study for at least 48-weeks and up to 108-weeks.  All study medications, clinic visits and lab tests will be provided by the study.

Studies for the complications of HIV

HIV and Hepatitis C:

ACTG 5294: This study is being done to see if adding the new drug, boceprevir to the standard combination of pegylated-interferon alfa 2b plus ribaviran is safe and whether it will help people with both HIV and HCV better fight their HCV. The third drug, Boceprivir, has already been approved by the Food and Drug Administration (FDA) recently for the treatment of people who are infected with HCV alone. Study drugs will be pegylated-interferon alfa 2b given as a weekly injection (under the skin), ribavirin based on weight (taken twice daily by mouth), and boceprevir (taken three times daily by mouth). All participants (both HCV treatment naïve [individuals who have never taken HCV medications] and treatment experienced [individuals who have previously taken HCV medications]) will be evaluated for a sustained virologic response (SVR) (undetectable HCV RNA levels found in the blood) 24 weeks after the end of treatment. You will be in this study for about 72-weeks

Women and Pregnancy

IMPAACT 1077HS

This 224-week study will determine if women who receive anti-HIV drugs during pregnancy to reduce the chance of having a baby born with HIV and continue after delivery should continue anti-HIV medications or stop at delivery.  Subjects will be randomized to either stop or continue their anti-HIV drug regimen after the baby is born.  To be eligible to participate in this study, subjects must have 4-weeks of anti-HIV drug therapy (2 prior to delivery), a CD4 cell count >400, and be willing to enter the study within 28 days after delivery.  Study medications are provided.

Vaccine Studies

ACTG 5128:

Participants of this study must be a current or past participant in an ACTG study and agree to have a one-time blood draw. Volunteers will consent to use the new DNA sample for unspecified genetic testing.

HIV/Asthma

This study is being done to evaluate whether anti-HIV medications result in a change to the immune system leading to asthma and asthma like symptoms. Subjects will be followed every 3-6 months for 1 year and divided into 2 groups after the first study visit; 1) those who are not on anti-HIV treatment and 2) those who start anti-HIV treatment. To be eligible for this study, participants must have never taken anti-HIV medications, be 18 years of age or older, have a CD4 cell count greater than 350 and less than 500, no history of COPD or asthma, and no AIDS defining illness. Please contact David Cosmar at (614) 366-2186 for more information.

Pilot HIV/Asthma

This study is comparing HIV positive individuals to determine if the prevalence of asthma and asthma like symptoms are greater among those on anti-HIV drugs. Subjects will undergo an evaluation for asthma, airway hyper-reactivity and allergies over 2 study visits which must occur within 14-days of each other. The study will compare two groups; 1) those who have never taken anti-HIV medications and 2) those on anti-HIV medications for 3 months or more. To be eligible to participate, volunteers must be 18 years or older, have no history of asthma or COPD, and have limited tobacco use less than 20 pack years. For more information, please contact David Cosmar at (614) 366-2186.                      

 

For More Information:

Please call (614) 293-8112 and ask for our screening nurse.