Current and Upcoming Studies

Moderna mRNA-1273-P301 - A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Case-Driven Study to Evaluate the Safety, Efficacy, and Immunogenicity of mRNA-1273 SARS CoV-2 Vaccine in Adults Aged 18 and Older. 

This study will determine the safety, efficacy, and immunogenicity of mRNA-1273 SARS--CoV-2 vaccine in outpatient adults who are at increased risk of COVID-19. The primary goal is to evaluate the efficacy of mRNA-1273 to prevent COVID-19 disease as compared to placebo.  Approximately 30,000 immunocompetent participants will be enrolled nationwide and receive vaccine in a 1-,28-day schedule. Between 25-40% of participants will be from the 65 and over age group. All participants will have blood drawn at D 1, 28, 57, 90, 180 and 365. Remote (phone calls or electronic) surveillance for safety and COVID-19 disease will start at day 1 and continue for at least a year (with safety surveillance up to 2 years).

Regeneron 10987-COV-2067 - A Master Protocol Assessing the Safety, Tolerability, and Efficacy Of Anti-Spike (S) SARS-Cov-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with COVID-19. 

The coronavirus spike (S) protein allows the virus to enter human cells and is central to viral infectivity by SARS-CoV-2.  Blockade of host cell entry by neutralizing antibodies against spike protein could be an effective treatment of COVID-19.  REGN10933 and REGN10987 are fully human monoclonal antibodies that bind spike protein and prevent entry of the virus into cells.  The purpose of this study is to evaluate the safety and tolerability and virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2.  Outpatients with COVID-19Participants will be randomized in a 1:1:1:1 allocation ratio to single dose co-administered REGN10933+REGN10987 combination therapy (low dose combination, or high dose combination), REGN10989 monotherapy, or placebo.

Regeneron 10987-COV-2066 - A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-Cov-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19. 

The coronavirus spike (S) protein allows the virus to enter human cells and is central to viral infectivity by SARS-CoV-2.  Blockade of host cell entry by neutralizing antibodies against spike protein could be an effective treatment of COVID-19.  REGN10933, REGN10987, REGN10989 are fully human monoclonal antibodies that bind spike protein and prevent entry of the virus into cells.  The purpose of this study is to evaluate the virologic efficacy of co-administered REGN10933+REGN10987 combination therapy and REGN10989 monotherapy compared to placebo.  Participants will be randomized in a 1:1:1 allocation ratio to one of the following: REGN10933+REGN10987 2.4 g (1.2 g of each mAb) IV single dose; REGN10933+REGN10987 8.0 g (4.0 g of each mAb) IV single dose; or Placebo IV single dose.

A5401/ACTIV-2: Adaptive Platform Treatment Trial for Outpatients with COVID-19
(Adapt Out COVID)

Adapt Out COVID is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. It begins with a phase II evaluation, followed by a transition into a larger phase III evaluation for promising agents.

Requirements to Enter Study:

• Outpatient adults (≥18 years)
• Documented positive SARS-CoV-2 molecular test (antigen or nucleic acid) ≤7 days prior to study entry
• Self reported symptoms of COVID-19 started ≤10 days from study entry
• The presence of select symptoms within 48 hours prior to study entry

A5359: Long-Acting Antiretroviral Therapy in Non-adherent Persons living with HIV (PLWH)

This study is investigating if Long-Acting Injectable ART will be more successful for people who are non-adherent to their HIV medications than oral standard of care regimens. The main advantages of LA ART in this population include infrequent dosing and directly observed therapy. A challenge for participants is that, to be eligible to receive LA ART, they will need to attain virologic suppression through adherence to their standard of care oral medications. Financial incentives will be used during the first 20 weeks of the study to motivate participants to be adherent to an oral regimen until they are eligible to be randomized to either the LA ART arm or the standard of care arm.

Requirements to Enter Study:

• PLWH who are 18 years of age or older.
• Prescribed ART for at least 6 months.
• Screening HIV RNA is greater than 200 copies.
• Women must not be pregnant, planning to become pregnant, or breastfeeding. Women who can become pregnant must agree to use 1 form of effective birth control.
• There is evidence of non-adherence to their HIV medications. Non-adherence to HIV medications will be defined as having one of the two criteria below:

1. Poor virologic response within the last 18 months (defined as <1 log₁₀ decrease in HIV-1 RNA from the participant’s historical baseline value or HIV-1 RNA >200 copies/mL at two time points at least 4 weeks apart) in individuals who have been prescribed ART for at least 6 consecutive months.

        2. Lost to clinical follow-up within the last 18 months with ART non-adherence for ≥6 consecutive months. Lost to clinical follow-up is defined as either no contact with provider or missed 2 or more appointments in a 6-month period. ART non-adherence is defined as a lapse in ART ≥7 days (consecutive or non-consecutive), in the 6-month period where they were lost to clinical follow-up per participant report.

A5371: A Single-Arm, Open-Label, Pilot study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, an Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

Is                                   Is a single-arm, open-label, pilot study of the effects of semiglutide on intra-hepatic triglyceride (IHTG) content in adults with HIV and hepatic steatosis, central adiposity, and insulin resistance. IHTG will be quantified by estimation of the IHTG using magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at two time points. Participants will also complete food diaries, adherence and strength assessments, and report on physical activity. Stool and blood samples will be collected at several visits

Requirements to Enter Study:

• 18 years of age or older
• Living with HIV Virologically suppressed
• Currently on ART for at least 24 weeks

A5379: B-Enhancement HBV Vaccination in persons Living with HIV (Bee-HIVe): Evaluation of Heplisav-B 

This study will evaluate a two- and three-dose regimen of HEPLISAV-B, each compared to a standard three-dose regimen of ENGERIX-B in HBV vaccine-experienced participants with anti-HBs <10 mIU/mL (Group A). It will also evaluate adults living with HIV with no known prior history of HBV vaccination (Group B) vaccinated with HEPLISAV-B.

Requirements to Enter Study:

• Individuals living with HIV at least 18 years old
• On current ART for more than 56 days
• CD4 >100 within 180 days of entry
• HIV-1 RNA < 1000 copies within 180 days of entry

        A5380: Glecaprevir/pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus            Infection (PURGE-C)

This study will evaluate acute HCV treatment response to G/P given for 4 weeks as assessed by sustained virologic response 12 weeks post-treatment (SVR12, defined as HCV RNA <lower limit of quantification, target detected or target not detected).

The study will also evaluate the safety and tolerability of combination oral antiviral therapy with G/P given for 4 weeks in persons with acute HCV-infection, regardless of genotype and HIV status.

Requirements to Enter Study:

• Age 18 years of age
• Mono or Co-infected
• Documentation of acute HCV infection
• If HIV positive, ARV untreated due to lack of indication per provider or on a stable antiretroviral regimen
• If HIV positive, HIV RNA <50 and CD4 >100, if on ART
• Must agree not to participate in a conception process
• HCV treatment naïve during current acute HCV infection
• Non-cirrhotic with no other chronic liver disease
• Hepatitis A and B negative
• Not pregnant or breastfeeding

The relationship between the gut microbiome composition and pulmonary immune function in HIV infection 

This study will characterize the relationship between gut microbes and their metabolites and immune phenotype and function of AM and T cells in the lung of HIV-infected individuals and HIV-negative controls using an integrated multi’omic approach. Particular gut microbiome compositions and their products/metabolites, will be associated with suppressed activation of pathogen response pathways and phagocytic activity of lung AMs and regulatory phenotypes of both AMs and T cell populations.

Requirements to Enter Study:

     ·         Men and women; 18 years to 70 years (All Cohorts)

·         Subjects with chronic HIV-1 Infection defined as a positive ELISA confirmed by a positive Western Blot or plasma      HIV-1 RNA level >1,000 copies/mL at any time in the past. (Cohorts A)

·         HIV-1 seronegative (Cohorts B & C)

·         Exhibits high-risk MSM behavior as determined with the risk behavior questionnaire (Cohort B)

·         Does not have high-risk MSM behavior as determined with the risk behavior questionnaire (Cohort C)

·         Body mass index (BMI) between 21-29 mg/kg² and weight stable for at least 3 months (All Cohorts)

·         Long-term ART (Cohort A): Must be on stable three-drug ART regimen for a minimum of 12 months prior to Visit 1.

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​​