Research studies current March 1 2025

Gilead   |   GS-US-563-5925 – ISLEND-1 (HIV Treatment – Comparing Weekly Dosing of Islatravir/ Lenacapavir vs. Daily Dosing of Biktarvy)

A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)

Currently Enrolling Diverse Populations Including: African American, Hispanic, Female, OR Any Race/Ethnicity who is 65 Years or Older

Gilead   |   GS-US-563-5926 – ISLEND-2 (HIV Treatment – Comparing Weekly Dosing of Islatravir/Lenacapavir vs. Daily Dosing of other Standard of Care Treatments)

A Phase 3 Randomized, Active-Controlled, Open-Label Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People with HIV-1 Who are Virologically Suppressed on Standard of Care

Currently Enrolling Diverse Populations Including: African American, Hispanic, Female, OR Any Race/Ethnicity who is 65 Years or Older

Gilead   |   GS-US-685-6819 (RSV Treatment)

A Phase 2 Randomized, Placebo-controlled Study of the Safety and Efficacy of Obeldesivir to Treat Non-hospitalized Adults with Acute Respiratory Syncytial Virus (RSV) Infection

Currently Enrolling Persons with a Confirmed Positive RSV Test with AT LEAST ONE of the Following Risk Factors: 60 Years or Older, Moderate or Severe COPD, Asthma, Chronic Lung Disease, OR Chronic Cardiovascular Disease.

Pfizer   |   C5091017 (Covid Treatment)

An Interventional Efficacy and Safety, Phase 3, Double-Blind, 2-Arm Study to Investigate Orally Administered Ibuzatrelvir Compared With Placebo in Non-Hospitalized Symptomatic Adult and Adolescent Participants With COVID-19 Who Are at High Risk of Progressing to Severe Illness

Currently Enrolling:

  • BMI ≥30 kg/m2;
  • Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes;
  • Chronic lung disease (ie, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, interstitial lung disease, history of pulmonary embolism, pulmonary hypertension);
  • Chronic lung disease (ie, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, interstitial lung disease, history of pulmonary embolism, pulmonary hypertension);
  • Asthma, requiring daily prescribed therapy
  • Cardiovascular disease, defined as history of any of the following: coronary artery disease, cardiomyopathies, myocardial infarction, stroke, transient ischemic attack, heart failure, angina with prescribed nitroglycerin, coronary artery bypass graft, percutaneous coronary intervention, carotid endarterectomy, and aortic bypass
  • Type 1 or Type 2 diabetes mellitus;
  • Mild to moderate renal impairment provided participant doesn't meet Exclusion Criterion 2;
  • Neurodevelopmental disorders (eg, cerebral palsy, Down's syndrome) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes and severe congenital anomalies), as long as the cognitive function allows consenting and completion of study procedures (eg, diaries); 
  • Sickle cell disease;
  • Moderate immunosuppression: Such as HIV infection with current CD4 count ≤350 cells/µL, T cell (cellular) immunodeficiencies, B cell (cellular) immunodeficiencies, Wiskott-Aldrich syndrome, Ataxia telangiectasia, Di George syndrome, Chronic granulomatous disease, Chronic granulomatous disease.

Current Studies

GlaskoSmithKline (GSK)   |   209639 – EMBRACE (HIV Treatment – 4 Month Infusion)

A Phase 2b Multicentre, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Subcutaneously as Either an Injection or Infusion with rHuPH20, in Combination with CAB LA to DTG/3TC in Virologically Suppressed Adults Living with HIV

Gilead   |   GS-US-528-9023 – PURPOSE-2 (HIV Prevention – 6 Month Injection)

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection

Gilead   |   GS-US-536-5939 (HIV Treatment – 6 Month Infusion)

A Phase 2 Randomized, Open-label Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With the Capsid Inhibitor Lenacapavir as Long-Acting Treatment Dosed Every 6 Months in Virologically Suppressed Adults With HIV-1 Infection

Gilead   |   GS-US-563-6041 (HIV Treatment)

A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Lenacapavir and Islatravir in Virally Suppressed People with HIV

Gilead   |   GS-US-621-6289 – ARTISTRY-1 (HIV Treatment)

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Gilead   |   GS-US-621-6290 – ARTISTRY-2 (HIV Treatment)

Phase 3 Double-Blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People with HIV-1

Gilead   |   GS-US-695-6509 – WONDERS-1 (HIV Treatment)

An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination with GS-4182 in Virologically Suppressed People with HIV

Merck   |   MK-8591A-051 (HIV Treatment)

A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy

Merck   |   MK-8591A-052 (HIV Treatment)

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

Merck   |   MK-8591A-054 (HIV Treatment)

A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

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