Publications & Presentations

Our clinical research center is widely recognized and highly sought-after because of our diverse community of members, our employees offering over 50 years of combined employee experience, and our proof of conducting all human trials. We are dedicated to providing our diverse community with exceptional research opportunities and treatments.

 

Our center is renowned for conducting FDA Phase 1b, 2, 3, and 4 clinical trials, focusing on human testing of antiviral drugs and vaccines for various diseases, including HIV, Hepatitis B, Hepatitis C, Covid, Mpox, HPV, and future studies on RSV and Herpes. With a portfolio of over 150 protocols, many of which have led to authorship of abstracts and manuscripts for publication, we have also undertaken pioneering first human dosing studies.

 

At the forefront of innovative treatment approaches, we explore novel concepts such as combining antiviral HIV drugs with broadly neutralizing antibodies (bNAb) or super antibodies to advance treatment strategies and potentially move towards a cure.

 

Among the notable studies conducted & manuscripts published by Team CrofootMD are:

  1. The HALLMARK publication shows how people with HIV infection at different T4Helper lymphocyte levels respond to vaccines. Significantly less response under 200 T4 count. This was published in 1992.

  2. We did the first pilot, proof of concept, study with Biktarvy and were a high enrolling site for the number of participants. We gave the first pill of Biktarvy to a human in the world.

  3. J&J HIV vaccine trial with almost 4000 subjects in the world. Dr. Crofoot gave the first injection in the world, unfortunately, it was not effective, and the FDA closed the trial.

  4. Dr. Crofoot gave one of the first 4 doses in the world using Liposomal Amphotericin for Histoplasmosis.

  5. Islatravir co-formulated with Lenacapavir is a published abstract at CROI 2024 in Denver This is the first ever published abstract with a once-a-week pill for the treatment of HIV.

  6. Derek Smith, NP co-authored recently a study done at our center to show how to teach individuals and partners how to self-exam rectum to diagnose anal cancer at an earlier stage.

  7. We did the first injection in the world of ViiV’s new bNAb (or super antibody) combined with monthly injections of Cabotegravir for treating HIV infection.

  8. We did the study and I co-authored Merck’s antiviral drug Molnupiravir, used to treat Covid, which was FDA approved 1 week after the manuscript was published in The New England Journal of Medicine.

  9. We administered the first subcutaneous injection in the world during the FDA Phase 1b pharmacological dosing study with the first-in-class Capsid Inhibitor to assess its duration of efficacy. We were surprised to find that it remained effective for 6 months. This drug is now known as Lenacapavir.

  10. We showed that Discovy worked very well for chronic Hepatitis B.

  11. In 1986, Dr. Crofoot was one of the first to use IV Fluconazole in an NIH study treating a cryptococcal meningitis HIV patient who had failed amphotericin.

  12. Dr. Crofoot was a co-author of a manuscript published in Nature Magazine showing the path with a first-in-class drug in a new HIV class of drugs called capsid inhibitors. We did some of the research with this drug discussed in this manuscript.

Publications & Presentations

HIV-1 infection kinetics, drug resistance, and long-term safety of pre-exposure prophylaxis with emtricitabine plus tenofovir alafenamide (DISCOVER): week 144 open-label extension of a randomized, controlled, phase 3 trial.

Wohl, David A Spinner, Christoph D Flamm, Jason Hare, C Bradley Doblecki-Lewis, Susanne Ruane, Peter JMolina, Jean-Michel Mills, Anthony Brinson, Cynthia Ramgopal, Moti Clarke, Gordon Crofoot, Martorell, Claudiab Carter, Christoph Cox, Stephanie Hojilla, J Carlo

The Lancet: HIV, August 2024

 

Safety of teropavimab and zinlirvimab with lenacapavir once every 6 months for HIV treatment: a phase 1b, randomized, proof-of-concept study.

Joseph J, Eron, Susan J Little, Gordon Crofoot, Marina Caskey

The Lancet: HIV, January 2024

 

Efficacy and Safety of Weekly Islatravir Plus Lenacapavir at 24 Weeks; a Phase II Study.

Amy Colson, Gordon Crofoot, Peter J. Ruane, Moti Ramgopal, Alexandra W. Dretler, Ronald G. Nahass, Gary Sinclair, Mezgebe Berhe, Chris Deaton, Angela S. Liu, Eva Mortensen, Martin S. Rhee, Elizabeth G. Rhee, Jared Baeten, Joseph J. Eron

CROI, Conference on Retroviruses and Opportunistic Infections, March 2024

 

The accuracy of anal self- and companion exams among sexual minority men and transgender women: a prospective analysis.

Alan G. Nyitray, Timothy L. McAuliffe, Cameron Liebert, Michael D. Swartz, Ashish A. Deshmukh, Elizabeth Y. Chiao, Lou Weaver, Ellen Almirol, Jared Kerman, John A. Schneider, J. Michael Wilkerson, Lu-Yu Hwang, Derek Smith, Aniruddha Hazra, and The Prevent Anal Cancer Palpation Study Team

The Lancet: Reg Health Am, March 31st, 2024

 

Lenacapavir administered every 26 weeks or daily in combination with oral daily antiretroviral therapy for initial treatment of HIV: a randomized, open-label, active-controlled, phase 2 trial.

Samir K Gupta, Mezgebe Berhe, Gordon Crofoot, Paul Benson, Moti Ramgopal

The Lancet: HIV, January 1st, 2023

 

Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials.

Chloe Orkin, Jean-Michel Molina, Gordon Crofoot, Pedro Cahn

The Lancet: HIV, December 2023

 

Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multi-Drug Resistant HIV: Week 104 Results.

Onyema Ogbuagu, Mezgebe Berhe, Gordon Crofoot, Gary J Richmond

Open Forum Infectious Disease, November 2023

 

Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial.

Onyema Ogbuagu, Sorana Segal‐Maurer,  Winai Ratanasuwan, Gordon Crofoot

The Lancet: HIV, July 2023

 

Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults.

Yoseph Caraco, Gordon Crofoot, Pablo Andres Moncada, Anna Nikolaevna Galustyan, Dany Badibanga Musungaie

New England Journal of Medicine: Evidence, February 1st, 2022

 

Perspectives of people living with HIV‐1 on implementation of long‐acting cabotegravir plus rilpivirine in US healthcare settings: results from the CUSTOMIZE hybrid III implementation‐effectiveness study.

Cindy P. Garris, Maggie Czarnogorski, Marybeth Dalessandro, Gordon Crofoot, William R. Spreen

Journal of the International AIDS Society, September 2022

 

Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomized, double-blind, placebo-controlled, phase 3 trial.

Ogbuagu, OnyemaRuane, Peter JPodzamczer, DanielSalazar, Laura C Henry, Gordon Crofoot

The Lancet: HIV, July 2021

 

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study.

Gregory D Huhn, Gordon Crofoot, Moti Ramgopal, Joseph Gathe, Robert K. Bolan

Clinical Infectious Diseases, December, 15th 2020

 

Clinical targeting of HIV capsid protein with a long-acting small molecule.

John O. Link, Martin S. Rhee, Tse Winston C, Jim Zheng, Gordon Crofoot, John R. Somoza

Nature, June 1st, 2020

 

High Rates of Virologic Suppression Achieved in HIV-1–Infected Adults Rapidly Starting Antiretroviral Therapy (ART) with the Single-Tablet Regimen (STR) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) 800/150/200/10 mg Regardless of Baseline Disease Characteristics: Week 48 Subgroup Analyses From the Phase 3 DIAMOND Trial.

Gregory D Huhn, MD, Moti Ramgopal, MD, Gordon Crofoot, MD, Joseph Gathe, Jr, MD, Sareh Seyedkazemi, PharmD, Patricia Cosler, PharmD, Richard Bruce Simonson, BS, Donghan Luo, PhD, Keith Dunn, PharmD

Open Forum Infectious Diseases, Volume 6, Issue Supplement 2, October 2019

 

Renal Outcomes for Participants Taking F/TAF vs. F/TDF for HIV PrEP in the DISCOVER Trial.

Anthony Mills, MD, Kimberly Workowski, MD, Thomas Campbell, MD, Paul Benson, DO, Gordon Crofoot, MD, Laura Salazar, MD, Onyema Ogbuagu, MD, Peter Shalit, MD, PhD, Benoit Trottier, MD, Christoph C Carter, MD 

Open Forum Infectious Diseases, Volume 6, Issue Supplement 2, October 2019

 

Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1.

Joseph Eron, Chloe Orkin, Douglas Cunningham, Gordon Crofoot

The Lancet, October 2019

 

Single Doses of Long-Acting Capsid Inhibitor GS-6207 Administered by Subcutaneous Injection Are Safe and Efficacious in People Living With HIV.

Eric Daar, Cheryl McDonald, Gordon Crofoot, Martin Rhee

Conference: European AIDS Conference, November 2019

 

Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48-week results of a randomized, open-label, multicentre, phase 3, non-inferiority trial.

Catherine Creticos, Eric S. Daar, Edwin DeJesus, Peter Ruane, Gordon Crofoot

The Lancet: HIV, June 1st, 2018

 

Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide.

Paul E. Sax, Edwin DeJesus, Gordon Crofoot, Douglas J. Ward, Paul Benson

AIDS, June 31st, 2018

 

Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomized, double-blind, active-controlled, non-inferiority phase 3 trial.

Alan Winston, Frank A. Post, Edwin DeJesus, Daniel Podzamczer, Gordon Crofoot,  Giovanni Di Perri

The Lancet: HIV, April 1st, 2018

 

Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomized, non-inferiority, phase 3 trials.

Christoph Stephan's Lab, Pedro Cahn, Juan G Sierra-Madero, Gordon Crofoot, José Ramón Arribas, Andrew Ustianowski

The Lancet, November 2018

 

Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide co-formulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomized, double-blind, multicentre, phase 3b, non-inferiority study.

Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane, Anthony LaMarca

The Lancet: HIV, May 1st, 2017

 

Switching from tenofovir disoproxil fumarate to tenofovir alafenamide co-formulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomized, double-blind, multicentre, phase 3b, non-inferiority study.

Chloe Orkin, Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane

The Lancet: HIV, May 1st, 2017

 

Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomized, double-blind, phase 2 trial.

Paul E. Sax, Edwin DeJesus, Gordon Crofoot, Douglas J. Ward, Paul Benson

The Lancet: HIV, April 1st, 2017

Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: A randomized, double-blind, parallel-group, phase 3, non-inferiority trial.

Pedro Cahn, Richard Kaplan, Paul E Sax, Gordon Crofoot, CB Hsiao

The Lancet: HIV, September 2017

Phase 3 Randomized, Controlled Trial of Switching to Fixed-dose Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Boosted Protease Inhibitor-based Regimens in Virologically Suppressed Adults: Week 48 Results.

Eric Daar, MD, Edwin DeJesus, MD, Peter Ruane, MD, Gordon Crofoot, MD, Godson Oguchi, MD, Catherine Creticos, MD, Jurgen K Rockstroh, MD, Jean-Michel Molina, MD, PhD, Ellen Koenig, MD, Ya-Pei Liu, PhD 

Open Forum Infectious Diseases, Volume 4, Issue Supplement 1, Fall 2017

Brief Report: Efficacy and Safety of Switching to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1/Hepatitis B–Coinfected Adults.

Gallant, Joel MD, MPH*; Brunetta, Jason MD†; Crofoot, Gordon MD‡; Benson, Paul DO§; Mills, Anthony MD‖; Brinson, Cynthia MD¶; Oka, Shinichi MD#; Cheng, Andrew MD, PhD**; Garner, Will PhD**; Fordyce, Marshall MD**; Das, Moupali MD, MPH**; McCallister, Scott MD

Journal of Acquired Immune Deficiency Syndromes, November 1, 2016

Tenofovir alafenamide (TAF) in a single tablet regimen in initial HIV-1 therapy.

Anton Pozniak, David Wohl, Melanie Thompson, Edwin DeJesus, Daniel Podzamcze, Jean Michel Molina, Gordon Crofoot, Christian Callebaut, Hal Martin, Scott McCallister

Journal: Sexually Transmitted Infections, Poster Presentation, June 2015

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate in the First Protease Inhibitor-Based Single-Tablet Regimen for Initial HIV-1 Therapy: A Randomized Phase 2 Study.

Anthony Mills, Gordon Crofoot, Cheryl McDonald, Peter Shalit, Jason A Flamm, Joseph Gathe Jr, 

Journal of Acquired Immune Deficiency Syndrome, August 1st, 2015

 

Tenofovir alafenamide versus tenofovir disoproxil fumarate, co-formulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomized, double-blind, phase 3, non-inferiority trials.

Paul E. Sax, David A. Wohl, Michael Yin, Gordon Crofoot,  Frank A. Post, Edwin DeJesus

The Lancet, June 7th, 2015

 

P100 Tenofovir alafenamide (TAF) in a single tablet regimen in initial HIV-1 therapy.

Edwin DeJesus, David Wohl, Anton Pozniak, Scott McCallister, Gordon Crofoot…

Journal of the International AIDS Society, April 2015

 

Switching from a Tenofovir Disoproxil Fumarate (TDF) to a Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen (STR): Week 48 Data in HIV-1-Infected Virologically Suppressed Adults.

Melanie Thompson, Javier Morales-Ramirez, Cheryl Mcdonald, Gordon Crofoot, Scott Mccallister

Open Forum Infectious Diseases, December 2015

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