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Current and Upcoming Studies

​                                                       Currently Enrolling Studies

A5332: Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)

HIV causes inflammation inside the body, which can contribute to diseases such as heart disease. HIV medications can lower inflammation somewhat, but levels of inflammation can remain higher compared to people who are not infected with HIV. Statins are used to lower cholesterol and levels of triglycerides, but some clinical trials have shown that statins may have other benefits. Pitavastatin is a statin used to treat high cholesterol and lowers triglyceride levels in the blood. The purpose of this study is to see if pitavastatin can prevent heart disease and heart disease related deaths in people with HIV infection who are taking HIV medications. This is a 6 year study with participants randomized to pitavastatin or a placebo. 

Requirements to Enter Study:

  • HIV+ men and women between the ages of 40 and 75 (women cannot be pregnant)
  • On ARTs for at least 6 months prior to study entry
  • CD4+ cell count >100
  • No history of cardiovascular disease (history of heart attack, stroke, etc.)
  • No history of cancer in the last 3 years
  • Not currently using statins

A5333s: Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE

This study plans to learn more about the effects of pitavastatin on the coronary arteries and the atherosclerotic plaque within the wall of these vessels, as well as, inflammatory biomarkers amount HIV+ individuals. This is a substudy of REPRIEVE and visits will occur at same time as main study visits (entry, month 4, and month 24).

A5361s – Pitavastatin to Reduce Physical Function Impairment and Frailty in HIV (PREPARE)

Aging with HIV may be associated with an earlier development of frailty or disability, including difficulties in tests of strength or walking speed. Few treatments have been shown to prevent or slow these impairments in people with or without HIV. Some studies have suggested that statins (ex, Pitavastatin) might be helpful in slowing frailty or disability. This might happen by decreasing fat within the muscle, or by decreasing inflammation markers in the blood. This substudy uses the A5332 (REPRIEVE) study to determine the impact of the drug pitavastatin on muscle. Study visits would coincide with A5332 visits and would include muscle strength and function tests. 

ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study

The purpose of this study is to determine whether screening and treatments of precancerous areas of the anus can prevent anal cancer. The lesions that cause anal cancer (high-grade squamous intraepithelial lesions or HSIL) are found in at least half of HIV infected men and 20% of HIV infected women. These lesions have no symptoms. Anal cancer is more common in HIV+ people than in the general population. If caught early, anal cancer is much more easily treated and with fewer side effects. 

Requirements to Enter Study:

  • ​HIV+ men and women

  • 35 years of age or older

  • Never been vaccinated against HPV (human papillomavirus)

  • You have HSIL

  • Never been treated for anal HSIL

  • Never have had cancer of the anus, vulva, vagina, or cervix​​

COPD and HIV: Immunosuppressive effects of smoking and HIV-1 on the development of lung disease

This study plans to learn more about pulmonary(lung) complications and disease in HIV/AIDS. ​The study consists of 2-4 clinic visits, with visits 2-4 testing for COPD (if not previously completed) which can include 6-minute walk, chest CT scan, lung function tests and questionnaire completion. All participants will be asked to undergo a bronchoscopy and donate a single stool sample.

Requirements to Enter Study:

  • Volunteers between the ages of 30 and 70 years old

  • Both HIV-negative and HIV-positive individuals with and without chronic obstructive pulmonary disease (COPD)

  • If HIV-positive, on a stable three-drug ART regimen with undetectable viral load for past 6 months​​​

​HIV and Lipodystrophy: Factors mediating gut microbiota dysbiosis and metabolic disease in HIV patients

This study aims to determine whether the development of lipodystrophy syndrome is related to changes in the types of bacteria that live in the gut(stool) that occur in HIV-infected individuals. The study will consist of 2-3 clinic visits which will include a physical exam, screening for lipodystrophy, blood collection, and a diet questionnaire. All participants will be asked to donate a single stool sample. 

Requirements to Enter Study:

  • Non-obese HIV-positive people between the ages of 18-70

  • Exhibiting the symptoms described above, indicating the possibility of lipodystrophy

Diet Modification Study: Diet/Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients  

This study plans to learn more about the short-term effects of consuming either a Western-style diet or an Agrarian-style diet (a diet low in fat and high in fiber/carbohydrates) on inflammatory and metabolic markers in people with and without HIV. The study will consist of 4 clinic visits which will include a physical exam and blood collection at each visit. At entry, participants will be asked to answer two dietary questionnaires and will be randomized to a 2-week supplied diet (Agrarian vs. Western). Visit 3 will supply each participant with dietary counseling and receipes to continue study diet for the following two weeks. All participants will be asked to donate 3 stool samples. Participants have the option to undergo a flexible sigmoidoscopy/mucosal biopsy at visits 2 and 4.

Requirements to Enter Study:

  • HIV-positive and negative men and women between the ages of 18 and 65  

  • BMI between 21-29 kg/m2 (non-obese)

  • If HIV-positive, treated with ART for at least 12 months with no changes in ARVs over the past 6 months

  • If HIV-positive, plasma HIV-1 RNA ≤50 copies/mL in preceding 6 months          

Exercise for Healthy Aging in HIV-Positive and Negative Individuals

This study aims to determine the best "dose" of exercise in people aging with HIV, and whether or not the dose differs from people without HIV. Exercise sessions (cardiovascular + strength training) are 3x/week at the Anschutz Exercise Research Facility (Leprino) for 6 months.

Requirements to Enter Study:

  • ​Men and women aged 50-70

  • If HIV-positive, on ART for at least 2 years with no detectable viral load

  • If HIV-positive, CD4 count >200

  • No active Hepatitis B or C, or chronic infections

  • If diabetic, must be well-controlled on oral medications (no insulin)

  • BMI between 20 and 40


                                             Upcoming Studies for Enrollment