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 people who have never taken medicines to treat HIV

ACTG 5303

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 5292

This study is for people who are HIV infected but have never taken HIV medications (referred to as antiretroviral medicine or ART). Each person will go into one of three groups. The 1st group will take Pravastatin for 24 weeks, the 2nd group will take Atripla for 12 weeks, then add Pravastatin for an additional 12 weeks while continuing the Atripla for 12 more weeks, and the 3rd group will take both Atripla and Pravastatin together for 24 weeks. The purpose of this study is to compare the effects of a) statin therapy alone, b) potent ART alone and c) potent ART combined with statin therapy on change over 8 weeks in cardiovascular risk in HIV-infected patients with CD4 cell counts greater than 500. This study is for 24-weeks and all study procedures and medication is provided 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.

Stusies for the complications of HIV

ACTG 5275

The main goal of this 1-year study is to see how taking atorvastatin affects inflammation biomarker blood tests in people infected with HIV that do not need to take medicine for high cholesterol. In addition to observing the effects of atorvastatin on blood tests, this study will see if atorvastatin is safe for people with HIV who are also taking medication for HIV. To be eligible to participate in this study you must be taking anti-HIV medications for at least 6 months and not planning to change medicines (the current regimen must include a protease inhibitor with ritonavir [Norvir®]), have an undectable HIV viral load, and have an LDL cholesterol of < 130.

ACTG 5293

ACTG 5293 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 and aspirin or fenofibrate for 24-weeks. 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. Low HDL-C is associated with an increased risk of heart disease. To enter this study you must be on stable anti-HIV medications for at least 48-weeks, have a CD4 >100,an undectable HIV viral load, and LDL cholesterol <160 and low HDL cholesterol. Compensation is provided for some visits.

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:

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.