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Current and Upcoming Studies


                                                        Currently Enrolling Studies

A5315: A phase I/II study of single dose romidepsin in HIV infected adults with suppressed viremia on antiretroviral therapy to assess safety, tolerability and activation of HIV-1 expression.

This study is designed to look at a one-time infusion of Romidepsin (RMD) to make sure it is safe, easy to take, and to see if it can wake up the hidden or sleeping HIV virus so that it will come out of hiding and be attacked or wiped out in an attempt to decrease the HIV reservoir. Each person will go into one of three groups (depending on when you enter this study) that will be assigned to one of three doses. Each group will enroll 15 subjects: 12 will receive RMD and 3 will receive a placebo (salt water solution) that does not contain RMD. Neither you nor the study staff will know whether you will receive RMD or the placebo (salt water solution). It is important to have placebos in this study to help us better understand any changes in viral load that may be seen.

During this study, you will be seen in the clinic up to 8 times. Study staff will let you know the requirements and length of each visit.  You will be admitted to the hospital for one to two nights to measure the amount of drug in your blood over time and to measure your viral load. 

Requirements to Enter Study

  • Taking combination antiretroviral therapy (ART) that does not include a protease inhibitor (PI)
  • HIV-1 RNA (viral load) < 50 copies/ml or undetectable for past 24 months
  • CD4+cell count > 300 cells/mm3
  • Men and non-pregnant women age >18 years
  • Agree to follow birth control requirements, as needed

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A5320: Viral hepatitis C infection long-term cohort study (H-HICS)

This is a five year observational study for participants who are co-infected with HIV and Hep C virus (HCV), or are mono-infected with HCV alone. Participants will begin a new Hep C treatment as part of the study (medication not provided). Blood will be collected to look at and compare the differences in each person’s HCV and genetic differences in each person that may play a role in success or failure of treatments. Questionnaires will be given to measure each person’s quality of life and how success/failure of treatment affects quality of life. This study will also help us understand how long resistance to new HCV medications lasts in a person and whether if affects future HCV treatment. 

Requirements to Enter Study:

  • HIV+/Hep C co-infected men and women who are at least 18 years of age
  • OR HCV mono-infected men and women who are at least 18 years of age
  • Completed treatment for Hep C in the last 12 months as part of a clinical trial
  • Not currently on Hep C treatment
  • Willingness to adhere to study visits twice a year AND a one-time visit prior to starting any new Hep C treatment study after V-HICS study enrollment

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A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV

A5324 is a study for HIV-infected individuals with undetectable HIV viral load who have mild neurocognitive impairment. Subjects will be randomized to one of three study arms to add either placebo for maraviroc (MVC) and placebo for dolutegravir (DTG) (Arm A), DTG active drug and placebo for MVC (Arm B), or MVC and DTG active drugs (Arm C) to their existing antiretroviral therapy (ART). The main purpose of the study is to see if intensification with MVC and DTG will improve neurocognitive performance and functioning in subjects who have at least mild neurocognitive impairment and have an undetectable viral load. Safety and tolerability of MVC and DTG when added to a stable ART regimen and the effect of the study drugs on markers in the blood and spinal fluid will also be studied.

Requirements to Enter Study: 
  • HIV-1 infected men and women at least 18 years of age
  • On current ART for at least 12 months 
  • Undetectable HIV viral load (<50 copies/mL) 
  • No more than one viral load between 50 and 200 copies/mL (only one “blip”) in the past 6 months 
  • At least mild HIV-associated neurocognitive impairment on neurocognitive tests done at screening 
  • Able to complete the neuropsychological tests in English
  • No medical condition not related to HIV that may cause cognitive impairment 
  • No current hepatitis C 
  • No prior or current use of any integrase inhibitor or MVC
  • No active syphilis or treatment for syphilis
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A5329: Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Persons with HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy

This study is for people coinfected with HIV and HCV, but are HCV treatment naïve. Current treatments for HCV usually consist of a combination of drugs including interferon, but new drugs are being developed that do not contain interferon. These regimens could be useful in treating people coinfected with HIV and HCV because they do not often respond well to interferon. This purpose of this study is to test if these drugs can effectively treat HCV and if they are safe and well tolerated in people who have HIV and HCV. Study drugs will be provided and participants will be treated for 12 or 24 weeks, based on randomization.

Requirements to Enter Study:
  • HIV and HCV infected men and women between the ages of 18 and 70 (women cannot be pregnant or currently breastfeeding)
  • No HIV genotypic resistance to any ARV medications prior to study entry
  • No history of virologic failure during treatment for HIV
  • HIV-1 viral load <50 copies/mL
  • On one of the following HIV-1 ARV regimens:
  • Raltegravir (Isentress) 400mg twice a day or darunavir (Prezista) 800mg once a day administered with ritonavir (Norvir) 100mg a day AND
  • Tenofovir (Viread) plus emtricitabine (Emtriva) once a day (or Truvada) or tenofovir (Viread) plus lamivudine (Epivir) once a day 
  • CD4 cell count ≥200 BMI from ≥18 to ≤38 kg/m2
  • HCV treatment naïve, HCV viral load >10,000 IU/mL, HCV genotype 1
  • Test to classify liver disease prior to entry
  • No other causes of liver disease
  • No active depression or uncontrolled mental health disorders
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A5334s: Pharmacokinetic Studies of Raltegravir and Darunavir/Ritonavir Before and During Combined Administration with ABT-40/r (ritonavir)/ABT-267, ABT-333 and Ribavirin in HIV-1/HCV Coinfected Subjects: A Substudy of A5329

The purpose of this substudy is to measure the ARVs and the HCV direct acting antivirals (DAAs) in the blood to see if the pharmacokinetics (process by which a drug is absorbed, distributed, metabolized, and eliminated by the body) change when the medications are taken together. This study will require two visits that coincide with the parent study (entry and week 4) and last 12+ hours. 
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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
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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). 
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A5336: A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults

Ruxolitinib is an FDA-approved medication to treat myelofibrosis, a disorder not related to HIV-1 infection in which bone marrow is replaced by scar (fibrosis) tissue. Many of the cytokines (regulators of the body’s reaction to infection, immune response, and inflammation) affected by myelofibrosis are also affected by HIV-1. Because ruxolitinib reduce these cytokines in people with meylofibrosis, it is proposed that it may also reduce inflammation in the bodies of people living with HIV-1 in whom the virus is suppressed by ART. Laboratory experiments have also shown that ruxolitinib may reduce the ability of HIV-1 to produce more copies of itself. This purpose of this study is to learn about the safety and tolerability of the use of ruxolitinib in people with HIV-1 infection who have an undetectable viral load. We want to learn whether ruxolitinib will decrease inflammation and immune activation in the body, whether it will affect the level of HIV in your blood, and how it interacts with ART in the blood. This is a 12 week study which will randomize participants to either 5 weeks of ruxolitinib or no study treatment. 

Requirements to Enter Study:
  • HIV+ men and women between the ages of 18 and 75
  • Be on continuous HIV-1 treatment for the last 2 years with undetectable viral load, and no plans to change medications for the duration of the study
  • CD4+ count ≥350
  • No other medical conditions or taking any medications that would be contraindicated for individuals taking study medication
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A5351s: Effect of Immune-Modulatory Interventions of Cytomegalovirus Replication during Suppressive Antiretroviral Therapy (substudy of A5336)

Cytomegalovirus (CMV) is a relatively common kind of herpes virus that is usually harmless but capable of producing severe problems for immunocompromised individuals. Recent studies suggest that even if no symptoms are present, when CMV replicates it could contribute to the inflammation experienced in HIV-1 infected individuals. The purpose of this substudy is to measure whether drugs designed to reduce inflammation in blood might also have an effect on the replication of herpes viruses in the genital tract and in the mouth (either increase or decrease frequency of replication). This is a substudy of A5336 and will use the same treatment (Ruxolitinib) as the parent study. 

Requirements to Enter Study:
  •  Coenrolled in an ACTG study with an immune-modulatory drug (A5336)
  •  Willing to donate genital secretions and oral swabs at study visits
  •  Willing to refrain from sexual activity for at least 48 hours prior to each study visit
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A5350: Safety, Tolerability, and Effects of the Probiotic VISBIOME Extra Strength on Gut Microbiome and Immune Activation Markers in HIV-Infected Participants on Suppressed Antiretroviral Therapy: A Phase II Study

The effective use of ART in people with HIV infection has produced significant gains in survival and has resulted in an aging population. The shift to an aging population has changed survival patterns, with a decrease in AIDS-related diseases and an increase in aging-related diseases such as cancer, cardiovascular disease, diabetes, and osteoporosis. Many factors contribute to the development of these conditions, including gastrointestinal disease, such as persistent inflammation and changes in the gut microbiome. Many researchers are studying the harmful effects of persistent inflammation and microbial changes in order to find ways to prevent complications. The purpose of this study is to learn more about the effects of VISBIOME Extra Strength on gastrointestinal damage in people who are HIV infected. VISBIOME Extra Strength is a probiotic with potential therapeutic effects on gastrointestinal diseases. This study hopes to learn if VISBIOME Extra Strength will decrease inflammation, improve gut health, and maintain these improvements after treatment. This is a 38 week study consisting of two treatment arms: Arm A receiving VISBIOME for 24 weeks and Arm B receiving a placebo for 24 weeks; with a follow-up of 12 weeks.

Requirements to Enter Study:
  •  HIV-infected men and women, ages 18 and older
  •  Be on continuous HIV treatment for the last 48 weeks with an undetectable viral load and no ARV interruptions longer than 7 continuous days.
  •  CD4 count ≥200 cells/mm3
  •  No chronic hepatitis B or C

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A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1 Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

This is a multicenter, open-label, randomized, active-controlled study to evaluate a switch from a regimen of a ritonavir-boosted protease inhibitor (PI) to two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) to MK-1439A in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants. MK-1439A is a single-tablet fixed-dose regimen (FDR) that combines MK-1439, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), 2 approved and commercially-available NRTIs. A single tablet of MK-1439A contains a full daily HIV treatment regimen of MK-1439 + lamivudine + TDF. 

Requirements to Enter Study:

  • Men and women, at least 18 years of age
  • HIV-1 positive with undetectable viral loads (<40 copies/mL by Abbott RealTime)
  • Receiving ART with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir in combination with 2 NRTIs continuously with HIV-1 RNA levels undetectable for ≥6 months
  • Be receiving his/her first or second PI-based ARV regimen
  • No history of using any approved or experimental NNRTI for any length of time
  • Had a genotype prior to starting his/her initial ARV regimen and have no known resistance to any of the study agents (MK-1439, TDF, or lamivudine)

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GSK Study 205543—Gemini: A Phase III, randomized, double-blind, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1 infected treatment-naïve adults

This study is being conducted to compare a simplified two-drug regimen of dolutegravir plus lamivudine with a standard three-drug first-line regimen in HIV infected, ART-naïve adults. The study is designed to demonstrate the non-inferior antiviral activity of DTG + 3TC once daily compared to DTG + TDF/FTC fixed dose combination once daily at 48 weeks. This study will characterize the long-term antiviral activity, tolerability, and safety of DTG + 3TC through week 148. The study aims to enroll 700 HIV-infected, ART-naïve participants; 350 participants will be in each arm.

Requirements to Enter Study:

  • HIV-1 infected
  •  ≥18 years of age
  • Treatment naïve
  • Screening VL must be 1000 to ≤ 500,000 c/mL​

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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​​​
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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

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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          

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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 

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. 
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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​
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GS2055 Study—Discover: A Phase III, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are at Risk of HIV-1 Infection

This is a double-blind study comparing the safety and efficacy of F/TAF versus F/TDF administered orally once daily (QD). All participants will remain on blinded treatment for at least 96 weeks, after which participants will be unblinded and offered the option to remain on open-label F/TAF in an open-label extension (OL). Those who chose to continue on study in the OL phase will take F/TAF for 48 weeks. This study intends on enrolling 5,000 MSM and TGW (male at birth) at risk of HIV-1 infection through sexual exposure with other men.

Requirements to Enter Study:

  • HIV-1 negative
  • MSM or TGW (male at birth) who have at least one of the following:
          • ​​​Condomless anal intercourse with at least two male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status),
          • ​​​Documented history of syphilis in the past 24 weeks, or
          • ​​​​Documented history of rectal gonorrhea or chlamydia in the past 24 weeks
  • 18 years of age
  • No history of HBV or HCV
  • Have not taken F/TDF or other approved/investigational agents for prevention of HIV-1 infection in 30 days prior to screening. 

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First Long-Acting Injectable Regimen--FLAIR Study: A Phase III, Randomized, Multicenter, Parallel-Group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naïve Adult Participants.

 

This study will be carried out over 120 weeks in 570 individuals (285 per arm). All participants will begin ABC/DTG/3TC regimen for 20 weeks prior to enrollment. Those with a VL <50 c/mL at week 4 will be randomized to either continue ABC/DTG/3TC or to begin CAB 30mg + RPV 25mg once daily upon enrollment. For the CAB + RPV arm, at week 4, the regimen will switch to long-acting IM injections. Two more IM injections will occur at week 8 and 12. 

 

Requirements to Enter Study:

  • HIV-infected
  • ​​ART-naïve participants
  • ≥18 years of age