HIV/AIDS studies

We address the challenges that patients with HIV and their physicians face with the long-term use of antiretroviral agents, the aging of the HIV-infected population and HIV/HCV co-infections. Clinicians are involved in evaluating the safety and efficacy of new treatment in clinical trials. We study the incidence and risk factors for AIDS-defining and non-AIDS-defining conditions such as cancers and other chronic diseases, and patterns of general disease screening and the use of preventive measures. Studies monitor adverse events after patients start on new retrovirals and identify prognostic markers in AIDS-related lymphoma.

A Phase 2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Investigate the Antiviral Effect, Safety, Tolerability, and Pharmacokinetics of STP0404 in Adults with HIV-1 Infection

The primary aim of this study is to evaluate the efficacy and safety of STP0404 in HIV infected patients.

Principal Investigator:

William J. Towner, MD, FACP, FIDSA

Funding Source:

PPD Development, LP

Funding Years:

2023 - 2027

Research Categories:

A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion with rHuPH20, in combination with CAB LA to Standard of Care in Virologi

The primary aim of this study is to evaluate the efficacy and safety of VH3810199 with rHuPH20 in HIV infected patients.

Principal Investigator:

William J. Towner, MD, FACP, FIDSA

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2023 - 2028

Research Categories:

A Phase 2b Single Arm, Repeat Dose Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of a New Formulation of Cabotegravir LA Injected Intramuscularly Q4M in Adolescent and Adult Participants at Risk of HIV Acquisition

The primary aim of this study is to evaluate the efficacy and safety of cabotegravir LA in prevention of HIV infection.

Principal Investigator:

William J. Towner, MD, FACP, FIDSA

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2024 - 2029

Research Categories:

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

The primary aim of this study is to evaluate the efficacy and safety of doravirine/islatravir when patients who are virologically suppressed on their prior agent are switched.

Principal Investigator:

William J. Towner, MD, FACP, FIDSA

Funding Source:

Merck Sharp and Dohme Corp.

Funding Years:

2023 - 2029

Research Categories:

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

The primary aim of this study is to evaluate the efficacy and safety of doravirine/islatravir when patients who are virologically suppressed on their prior agent are switched.

Principal Investigator:

William J. Towner, MD, FACP, FIDSA

Funding Source:

Merck Sharp and Dohme Corp.

Funding Years:

2023 - 2029

Research Categories:

A Phase 3, Randomized, Double-blind, Active-controlled 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)

The primary aim of this study is to evaluate the efficacy and safety of islatravir/lenacapavir in HIV infection.

Principal Investigator:

William J. Towner, MD, FACP, FIDSA

Funding Source:

Gilead Sciences, Inc.

Funding Years:

2024 - 2029

Research Categories:

A Phase 3, Randomized, Open-Label, Active-Controlled 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

The primary aim of this study is to evaluate the efficacy and safety of islatravir/lenacapavir in HIV infection.

Principal Investigator:

William J. Towner, MD, FACP, FIDSA

Funding Source:

Gilead Sciences, Inc.

Funding Years:

2024 - 2029

Research Categories:

Addressing cancer treatment disparities for persons with HIV

This study is to investigate disparities by HIV status and modifiable risk factors for delays in cancer treatment initiation, treatment completion, and short- and long-term adverse events for persons with HIV (PWH) who were members of the Veteran’s Administration or Kaiser Permanente, the two largest healthcare systems in the United States. Study findings will provide necessary data to inform HIV-specific cancer treatment guidelines and improve cancer care delivery and outcomes for PWH.

Site Principal Investigator:

Rulin C. Hechter, MD, PhD

Funding Source:

National Cancer Institute (NCI)

Funding Years:

2021 - 2026

Research Categories:

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CDC/Kaiser PrEP Data

The primary aim of this study is to evaluate patterns of PrEP utilization.

Principal Investigator:

William J. Towner, MD, FACP, FIDSA

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2024 - 2026

Research Categories:

Developing an HIV Specific-Specific Prevention Index Using Electronic Medical Record (HIV PI)

The goals of this study are to assess in HIV-infected patients, the degree of association between successful general clinical care by HIV disease-treating providers (reflected in overall adherence to recommended general prevention and screening guidelines) and higher-quality HIV-specific care and related clinical outcome.

Principal Investigator:

Chun Chao, PhD, MS

Funding Source:

Agency for Healthcare Research and Quality (AHRQ)

Funding Years:

2010 - 2013

Effects of HIV Pre-Exposure Prophylaxis (PrEP) on Cardiovascular-Kidney-Metabolic Health and Risk for Cardiovascular Disease

The U.S. Ending the HIV Epidemic initiative aims to expand HIV pre-exposure prophylaxis (PrEP) provision to over a half million at-risk Americans by 2025. This multisite cohort study would be the first to systematically assess the impact of PrEP on cardiovascular-kidney-metabolic health among diverse populations using comprehensive electronic health record data from three large integrated healthcare systems. The knowledge gained from this study will help inform evidence-based PrEP guidelines and develop tailored prevention strategies to reduce cardiovascular morbidity and mortality among people taking PrEP.

Principal Investigator:

Rulin C. Hechter, MD, PhD

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2025 - 2029

Research Categories:

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