Penn Therapeutics CRS

Site Details

LOCATION

502 Johnson Pavilion

Philadelphia, PA. 19104

(215) 349-8092

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Site Type

CRS

CRS Leader

Pablo Tebas

pablo.tebas@uphs.upenn.edu

215-349-8092

Site Trials

Treatment Naïve

Active, Not Recruiting

A5388: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission

Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broadly neutralizing antibodies (bNAbs), when administered with ART, also have the potential to prevent the HIV virus from being able to reproduce.

 

This is a randomized, placebo-controlled research study that will enroll adults with recently diagnosed AHI. All participants will begin ART at entry and receive a single dose of two bNAbs (VRC07-523LS and PGT121.414.LS) or placebos. Everyone will be followed for about 1 year after starting ART, then stop ART for up to 2.5 years, then be followed for 1 year after restarting ART.

Treatment Experienced

Open and enrolling

A5385: An Observational Post-Intervention Cohort Destination Protocol

This study is a two-step, non-interventional extension study for individuals participating in another interventional HIV cure trial (parent study) that includes an analytical treatment interruption (ATI) (stopping anti-HIV therapy [ART] while monitoring viral load). Participants will be individuals who achieved post-intervention control (PIC) (maintaining HIV suppression after treatment interruption) in their parent study.

 

Step 1 will consist of an extended ATI period in which PICs will be monitored for safety, viral, and immune outcomes. Time to viral rebound and restart of antiretroviral therapy (ART) will be measured. Participants will begin Step 2 if they meet ART restart criteria and will be monitored for safety, immune, and viral outcomes through 48 weeks after ART restart.

Treatment Experienced

Open and enrolling

A5374: A Phase I/IIa Randomized, Placebo-Controlled Trial of Conserved-Mosaic T-cell Vaccine in a Regimen with Vesatolimod and Broadly Neutralizing Antibodies in Adults Initiated on Suppressive Antiretroviral Therapy during Acute HIV-1

Current antiretroviral therapy (ART) does not cure HIV. ART just holds the virus in check so it cannot multiply and destroy the immune system. When most people talk about a cure for HIV, they generally imagine a cure that would remove all virus from the body. However, many researchers are looking for a different approach, known as a functional cure, that would improve the immune system response to HIV so that it controls the virus and allows for longer periods during which a person with HIV could stop taking ART.

 

Treatment Experienced

Open and enrolling

A5403: Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study

Transgender women (TW) are the fastest-growing group of people with HIV. Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed to help providers when it comes to choosing HIV medications in TW on Feminizing Hormone Therapy (FHT). This is an open-label, non-randomized trial of adult TW on three types of HIV medications who will receive estradiol for FHT for 48 weeks.

HIV Cure

Open and enrolling

A5341s: Size and Decay of HIV-1 Reservoirs in Tissues and Cerebrospinal Fluid in Participants on Long-Term Antiretroviral Therapy: A substudy of the ACTG HIV Reservoirs Cohort (AHRC) Study

A5341s: A5321 Sampling Substudy

 

Longitudinal Sampling Substudy of A5321 is collecting information from measures of different HIV reservoirs, including where HIV can be found, whether different reservoirs have different amounts of HIV, the best way is to measure the amount of HIV in different reservoirs, and whether the amount of HIV found in one reservoir says anything about the amount of HIV in other reservoirs.

See More Info on A5321 to learn more.

HIV Treatment

Closed to accrual

A5377: Tri-specific Antibody

The first study of a broadly neutralizing antibody called SAR441236 in humans, will determine if an infusion is safe and tolerable and will measure the amount of SAR441236 in the blood over time. It will also evaluate whether SAR441236 can reduce the amount of HIV in a person’s blood.

Antibodies that develop naturally against HIV recognize and attach to one part of the virus so that the body’s immune system can try to attack it. Antibodies are usually made by a person’s own immune system, but they can also be manufactured as a drug. SAR441236 has been manufactured to attach to three parts of the HIV virus at the same time, and to neutralize (or block) the ability of the virus to infect more cells.

A5377 is the first study of SAR441236 in humans. This study will enroll two groups of people with HIV: Arm A—people who are on an anti-HIV regimen with an undetectable HIV viral load will receive either SAR441236 or placebo in four increasing dosing groups; and Arm B—people who have never received anti-HIV medications will receive SAR441236 in four increasing dosing groups.

HIV Treatment

Open and enrolling

A5359: The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE - A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals

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

· Step 1 is the induction phase and all participants receive SOC oral ART. Participants receive financial incentives for meeting study-specified goals.

· Step 2 is the randomization phase and participants are randomized 1:1 to receive LA injectable ART (cabotegravir and rilpivirine injections) or continue on SOC for 52 weeks.

· Step 3 is the crossover/continuation phase. Participants randomized to LA ART will continue that therapy, and eligible SOC participants will cross-over to receive LA ART for 52 weeks.

· Step 4 is the observational phase that switches participants who received at least one LA ART injection and are no longer eligible for injections back to locally sourced SOC oral ART for 52 weeks.

HIV Cure

Closed to accrual

A5354: Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses

Will evaluate whether starting antiretroviral drugs very early in HIV infection will limit the virus from getting into hidden areas of the body (reservoirs) and change how the immune system helps to control the virus.

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.

HIV Cure

Treatment Experienced

Open and enrolling

A5321: Decay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study

AHRC (pronounced “ARC”) is a study of differences and changes over time in HIV reservoirs (groups of HIV-infected cells that “hide” from anti-HIV medications). This study enrolls people into one of six groups, based on their different HIV treatment histories. The current version of this study is only enrolling for Group 6, which will include people who acquired or are suspected to have acquired HIV while taking long-acting cabotegravir (LA CAB) for pre-exposure prophylaxis (PrEP).

Hepatitis

HIV comorbidities and complications

HIV Cure

HIV Treatment

Tuberculosis

Open and enrolling

A5128: Plan for Obtaining Informed Consent to use Stored Human Biological Materials (HBM) for Currently Unspecified Analysis.

Designed to develop a standard operating procedure to establish a storage bank for specimens for future HIV DNA analyses.

Informed consent to use stored specimens for currently unspecified/ genetic analyses.

HIV Treatment

Closed to accrual

A5357: A Study of Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) to Maintain Viral Suppression in Adults Living with HIV-1

This study is for people with HIV who have an undetectable viral load. The study will evaluate the safety and effectiveness of a combination of two medications. The first drug is called long-acting cabotegravir (CAB), which will be given orally during Part 1 of the study and then as an injection every 4 weeks during Part 2 of the study. The second drug is called VRC07-523LS, which is a monoclonal antibody. A monoclonal antibody targets human proteins rather than attacking the virus directly. This drug will be given intravenously (directly into a vein) over about 15 to 30 minutes every 8 weeks.

 

HIV comorbidities and complications

Closed to accrual

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

You are being asked to take part in this research study because you are infected with HIV, the virus that causes AIDS, and were previously followed in the ALLRT (A5001) study and are 40 years of age or older. This study, A5322 (also known as the HAILO study), is a long-term follow-up study of persons who have HIV and received their first treatment for HIV known as antiretroviral medications, in certain clinical trials that were done by the AIDS Clinical Trials Group (ACTG).

 

HIV comorbidities and complications

Closed to accrual

A5332: REPRIEVE Trial

In this study, people between the ages of 40 and 75 with HIV will be randomized (like flipping a coin) to take the pill pitavastatin OR a placebo (non-active pill) to see if pitavastatin can help prevent heart disease and death in people who are taking HIV medication. You will not know if you are taking pitavastatin or placebo. The REPRIEVE trial will enroll about 7500 people from several countries.

HIV comorbidities and complications

Closed to accrual

A5361s: Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)

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.

HIV Cure

Closed to accrual

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

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.

Hepatitis

Closed to accrual

A5379: B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEe-HIVe): Evaluation of HEPLISAV-B

A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.

HIV comorbidities and complications

Closed to accrual

A5391: Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide

Weight gain after starting HIV therapy is common, but recent studies have found that some people with HIV (PWH) who are taking an integrase inhibitor (INSTI) combined with a tenofovir alafenamide (TAF) regimen may gain more weight than people taking other drug combinations.  A rising number of PWH are overweight or obese, and a higher body mass index (BMI) increases the risk for diabetes, heart disease and stroke.

 

This study will include PWH who have been virally suppressed on a regimen consisting of an integrase inhibitor (INSTI) and TAF/FTC or TAF/3TC, and have a BMI of 30 kg/m2 (the cut-off for obesity) or greater. This research study is trying to find out if they could gain less weight, or maybe lose weight, after switching to a regimen containing doravirine (DOR) with TAF/FTC (or TAF/3TC), or DOR with the related medication tenofovir disproxil (TDF/FTC [or TDF/3TC]) as compared to continuation of their current INSTI plus TAF regimen.

 

HIV Cure

Open and enrolling

A5386: A Phase 1 Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) with and without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption

Scientists are looking for ways to effectively clear HIV that rests in areas of the body where standard antiretroviral treatment (ART) is unable to reach. IL-15 superagonist (N-803) appears to reactivate HIV that is “asleep” and is also thought to increase the body’s natural immune response to HIV. Broadly neutralizing antibodies (bNAbs), such as 10-1074 and VRC07-523LS, have been shown to control growth of HIV in the blood and to increase the body’s immune response to HIV. N-803 alone or in combination with bNAbs may provide greater control of HIV than previous efforts.

COVID-19 and Mpox

Closed to accrual

A5404: SARS-CoV-2 Immune Responses after COVID-19 Therapy and Subsequent Vaccine

Right now there is no medicine proven to treat COVID-19 in people who are not sick enough to be hospitalized. Researchers will be testing different investigational medicines that they believe are most likely to help people with COVID-19.

They want to see if these investigational medicines:

  • Are safe for those who need them
  • Can help people get better faster
  • Can get rid of the virus
  • Can help keep oxygen levels up
  • Can keep people from getting sicker
  • Can prevent people from having to go to the hospital

The whole study lasts about 6 months (24 weeks).

During the study you would have in-person visits with tests to check on your health. Most of these visits happen during the first month of the study.

You would also have phone calls or videos chats with the researcher from your home.

The study team will give you a diary to keep track of your temperature each evening and any symptoms you have. You’ll be asked to fill out this diary for the first 28 days.

If the study is right for you, you will have your first visit, or entry visit, to meet with a researcher for tests and to be placed in a treatment group.

Each study medicine will be compared to a placebo. A placebo looks like the real drug but doesn’t have any actual medicine in it. This gives researchers something to compare the study medicine to. You would not know if you are receiving the study medicine or placebo until the end of the study. If a standard treatment for COVID-19 is found during the study, that treatment will be used instead of placebo. Different medicines may be tested during the study at the same time. One type of investigational medicine you might receive is called a monoclonal antibody. Antibodies are naturally made by your body to help fight disease. Monoclonal antibodies are made in the lab and help your body attack invaders, such as viruses, to keep them from entering your cells. Once you are placed in a treatment group, you will receive more information on that investigational medicine being tested, including any possible side effects.

 

To learn more about this study click here.

HIV comorbidities and complications

Closed to accrual

A5355: Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®) in Adults with Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART with Conserved Immune Function

Since the early days of the HIV epidemic cytomegalovirus (CMV) has been one of the most common and devastating opportunistic infections (OIs) experienced by people with HIV. CMV is a common virus that usually causes few, mild, or no symptoms and typically remains in the body for life; in people with weakened immune systems, however, CMV can cause more serious symptoms affecting the eyes, lungs, liver, esophagus, stomach, and intestines ). HIV and CMV can work together against our bodies’ defenses, making transmission of each virus easier. We would like to change this.

In this study, you will be randomized to one of the study treatment arms. You will receive either Triplex® study vaccine or placebo by injection into the muscle of your shoulder 2 times; once when you enter the study and again about 4 weeks later.

HIV comorbidities and complications

Closed to accrual

A5383: Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)

This study will include 180 participants. Participants will have HIV and Cytomegalovirus (CMV). CMV is common virus that many people living with and without HIV have been exposed to. You do not need to know if you have CMV to be considered for study participation. About half of the study participants will be given study medication to be taken once daily for 48 weeks. The study medication will be letermovir, an FDA approved medication to prevent CMV. The other half of
participants will not receive any additional medication. The study will last about 1 year and 2 months.

COVID-19 and Mpox

Open and enrolling

A5418: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Disease

A5418 (STOMP) is a study of tecovirimat (also known as TPOXX) for the treatment of human monkeypox virus (HMPXV) disease.