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Past Studies

Active, but no longer enrolling

EXIT-CJS

About:

The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.

Contact:

📧 RWAHEngage@njms.rutgers.edu
📞 1 (844) 782-6765

 

A5359: The LATITUDE Study

About:

This study is investigating whether long-acting injectable medications will be more successful for people who are non-adherent to their HIV medications than oral regimens.

This four-step study compares Long-Acting (LA) Injectable Antiretroviral Therapy (ART) to standard of care (SOC) oral ART in previously non-adherent individuals.

Contact:

📧 RWAHEngage@njms.rutgers.edu
📞 1 (844) 782-6765

 

A5322: Long-Term Follow-up of Older HIV-infected Adults in the ACTG: Addressing Issues of Aging, HIV Infection and Inflammation (HAILO)

About:

The purpose of this study is to help us learn about how HIV, aging and the immune system (how your body fights infection) all interact with each other to see how they relate to the development of illnesses such as kidney disease, cancer, and diabetes. This study will also see if treating people with HIV for these other illnesses works as well as treating people without HIV for the same illness.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

A5332: REPRIEVE Trial

About:

HIV causes inflammation (irritation) inside the body that cannot be felt but can be measured. Inflammation may contribute to diseases such as heart disease that have become some of the leading causes of death in people with HIV. HIV medications can lower inflammation somewhat, however sometimes the levels of inflammation can remain higher compared to people who do not have HIV.

Statins (name of the group of medicines that pitavastatin belongs to) are used to lower the levels of cholesterol and triglycerides (fat in the blood) that people make. Studies have shown that statins may have other benefits. For example, heart disease and the levels of inflammation can be lowered by statins.

Pitavastatin is a statin that, along with a diet, has been approved by the US Food and Drug Administration for the treatment of high cholesterol. It also lowers triglyceride levels in the blood.

The main purpose of this clinical trial is to see if pitavastatin can prevent heart disease and heart disease related deaths in people with HIV who are taking HIV medications.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

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

About:

Aging with HIV may be associated with an earlier development of frailty (weakness) 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 the class of drugs called statins, such as 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 study uses the REPRIEVE Trial (A5332) and the REPRIEVE Mechanistic Substudy (A5333s) to study the impact of pitavastatin on muscle.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase Inhibitors

About:

While antiretrovirals known as ARV’s (group of medicines used to treat HIV) have provided very effective treatment of HIV, cure of HIV from the body has not been possible. One of the reasons may be due to virus hiding in resting (or ‘latent’) immune cells. This reservoir (the hidden virus) is able to reproduce itself and serves as source of infection if ARV’s are stopped. Some investigational medications have been shown to wake up latent (sleeping) immune cells allowing them to get rid of the virus they have inside them. However, these therapies are only partly effective and results vary in different people. Preliminary studies have shown that these therapies may be less effective in women due to female hormones.

This study will evaluate one of the medications (Vorinostat) that have been shown to reverse latency in combination with another medication (Tamoxifen) that researchers hope will enhance that effect, specifically in women.

The primary purpose of this study is to see if Tamoxifen given with Vorinostat is safe. It will also study if Tamoxifen will enhance the ability of Vorinostat to reverse latency in post-menopausal women.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

CoVPN 5002: The COMPASS Study

About:

The COMPASS Study – Community Prevalence of SARS-CoV-2 Study (CoVPN 5002) will estimate the percentage of people affected by SARS-CoV-2 in selected communities in the United States. SARS-CoV-2 is the name of the virus that causes the coronavirus disease, called COVID-19. The COMPASS Study will evaluate the extent of COVID-19 in these communities; assess knowledge, attitudes and behaviors related to SARS-CoV-2 and COVID-19; model the potential impact of different prevention interventions; and guide future SARS-CoV-2 prevention studies and COVID-19 treatment studies in these communities. It will also provide valuable samples for important laboratory assessments related to the acquisition of SARS-CoV-2 and impact of the COVID-19 pandemic.

For more information regarding this study, please visit www.compassstudy.org.

 

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

HPTN 083

About:

A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

MOSAICO: HPX3002/HVTN706

About:

Mosaico is a large study that will try to prove whether the experimental vaccine regimen can prevent HIV infection in North America, Latin America, and Europe. If Mosaico can show that the study vaccine regimen works, it will be a very important step on the way to finding a safe and effective vaccine for the prevention of HIV.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

The RUXCOVID clinical trial

About:

RUXCOVID is a global, randomized, double-blind, placebo-controlled, 29-day, multi-center Phase III study evaluating the efficacy and safety of ruxolitinib plus standard of care (SoC) therapy in patients aged ≥12 years with COVID-19 associated cytokine storm.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

START Study

About:

INSIGHT’s START (Strategic Timing of AntiRetroviral Treatment) is an international randomized trial to determine whether starting antiretroviral therapy (ART) early (before CD4 drops to less than 500 cells/mm³), rather than waiting until CD4 drops to less than 350 cells/mm³ (when evidence from randomized trials supports starting ART), reduces the occurrence of serious morbidity and mortality. START began enrollment in April 2009 at 215 clinics in 35 countries around the world. Enrollment was completed on 23 December 2013, with 4,688 participants. Baseline characteristics of participants in START and its sub-studies are described in the April 2015 supplement to HIV Medicine.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

No longer active or enrolling

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

About:

People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The purpose of this study is to evaluate if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral [ARV] medications) to participants’ existing ART regimens will improve participants’ neurocognitive performance.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

A5354: Early ART in Acute HIV

About:

This study will include people who have very recently been infected with HIV and will start anti-HIV (antiretroviral) drugs right away to see how this may change HIV’s impact on the body.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765

 

A5360: MINMON Study-Monitoring SOF/VEL in Treatment Naïve, Chronic HCV Participants

About:

This study is being done to see if a minimal monitoring approach is effective and safe when providing HCV treatment. The minimal monitoring approach will require fewer study visits and lab tests with no medication refills. This study is trying to see whether taking an HCV treatment with fewer clinic visits and laboratory tests can cure just as many people as the standard approach that uses more visits and laboratory tests. The results of this study will be compared with what has been observed in other studies using a standard approach.

Contact:

📧 ResearchWithAHeart@njms.rutgers.edu
📞 1 (844) 782-6765