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 provide 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 showing 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.
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  2. We did the first pilot proof of concept study and were high enroller with Biktarvy. We gave the first pill to a human in the world.
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  3. J&J HIV vaccine trial with almost 4000 subjects in the world. I gave the first injection in the world, unfortunately it was not effective, and the FDA closed the trial.
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  4. I gave one of the first 4 doses in the world using Liposomal amphotericin for Histoplasmosis.
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  5. Islatravir coformulated 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 treatment of HIV.
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  6. Derek Smith NP coauthored 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.
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  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.
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  8. We did the study and I coauthored Merck’s antiviral drug Molnupiravir which was FDA approved 1 week after the manuscript was published in The New England Journal of Medicine.
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  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. Lenacapavir was recently found to be 100% effective as PrEP to prevent HIV transmission. Science magazine listed this drug as the 2024 breakthrough of the year.
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  10. We showed that Descovy worked very well for chronic Hepatitis B.
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  11. In 1986 I was one of the first to use IV Fluconazole in an NIH study treating a cryptococcal meningitis HIV patient who had failed amphotericin.
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  12. I was a coauthor 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 research with this drug discussed in this manuscript.

Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons

Colleen F. Kelley, M.D.,M.P.H.  Maribel AcevedoQuiñones, M.D., AllisonL. Agwu, M.D., Anchalee Avihingsanon, M.D.,Ph.D., Paul Benson, D.O., Jill Blumenthal, M.D., Cynthia Brinson, M.D., Carlos Brites, M.D., Ph.D., Pedro Cahn, M.D., Ph.D., Valeria D. Cantos, M.D.,Jesse Clark, M.D.. Meredith Clement, M.D., Cathy Creticos, M.D., Gordon Crofoot, M.D .Ricardo S. Diaz, M.D.

The New England Journal of Medicine, November 27, 2024

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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, Crofoot, Gordon Martorell, Claudiab Carter, Christoph Cox, Stephanie Hojilla, J Carlo.

The Lancet HIV, 2024 July

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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, 2024 January

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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

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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

Lancet Reg Health Am. 2024 Mar; 31

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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, PaulBenson, Moti Ramgopal

The Lancet. HIV 2023-01-01

 

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

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 Non hospitalized Adults

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

NEJM Evidence 2022-02-01

 

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 2022-September

 

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, Onyema Ruane, Peter J Podzamczer, Daniel Salazar, 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, 2020-12-15

 

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, 2020-07-01

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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 48Subgroup 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 Oct- 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  2019-November

 

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 2018-07-01

 

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 2018-07-31

 

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 2018-04-01

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Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 andGEMINI-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  2018-November

 

Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated 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 2017-05-01

 

Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated 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 2017-05-01

 

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, DouglasJ. Ward, Paul Benson

The Lancet. HIV 2017-04-01

 

Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1infection: 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   2017-September 

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, AndrewMD, PhD**; Garner, Will PhD**; Fordyce, Marshall MD**;Das, Moupali MD, MPH**; McCallister, Scott MD

JAIDS Journal of Acquired Immune Deficiency Syndromes November1, 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 Martin8, Scott McCallister8

Journal Sexually Transmitted Infections, Poster Presentation 2015-June

 

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 1, Gordon Crofoot Jr, Cheryl McDonald, Peter Shalit, Jason A Flamm, Joseph Gathe Jr.

Journal Acquired Immune Deficiency Syndrome, 2015-Aug-1

 

Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated 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.

Lancet 2015-06-27

 

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 2015-April

 

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 2015-December

 

Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a Phase III b, open-label single-arm trial

Karen T. Tashima, Gordon Crofoot, Frank Tomaka, Thomas N.Kakuda, Anne Brochot

AIDS Research and Therapy 2014-12-01

 

Phase IIIb, open-label single-arm trial of darunavir/ cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV-1-infected treatment-nave adults

Karen T. Tashima, Gordon Crofoot, Frank Tomaka, Thomas N.Kakuda, Anne Brochot

Journal of the International AIDS Society 2014-11-02

 

Switching From Twice-Daily Raltegravir Plus Tenofovir Disoproxil Fumarate/ Emtricitabine to Once-Daily Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir Disoproxil Fumarate in Virologically Suppressed, HIV-1–Infected Subjects: 48 Weeks Data

Mills, G. Crofoot, R. Ortiz B. Rashbaum, W. Towner, D. Ward

HIV Clinical Trials  2014-March

 

Long-Term Efficacy and Safety of EVG/ COBI/ FTC/ TDF Compared to EFV/ FTC/ TDF in HIV-1-Infected, Treatment-Nave, Black Versus Non-Black Subjects

David Hardy, Peter Ruane, Javier Szwarcberg, Gordon Crofoot, Kimberly Workowski

Conference: ID Week 2013 Meeting of the Infectious Diseases Society of America 2013-October

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HIV-treating physicians in Houston express their professional opinions on the public health implications of antiretroviral therapy

G. Crofoot, Ben J. Barnett, E. C. Nannini, P. D.Salvato

Research Initiative, Treatment Action 2000-12-01

 

Pharmacokinetics of Liposomal Nystatin in Patients with Human Immunodeficiency Virus Infection

Adan Rios, Michael G. Rosenblum, Gordon Crofoot, Robert P.Lenk, Alan C. Hayman

The Journal of Infectious Diseases 1993-07-01

 

Antibody to Capsular Polysaccharides of Streptococcus pneumoniae after Vaccination of Human Immunodeficiency Virus-Infected Subjects with 23-Valent Pneumococcal Vaccine

Maria C. Rodriguez-Barradas, Daniel M. Musher, Gordon Crofoot, ChristopherJ. Lahart, Christine E. Lacke, Jean E. Groover

The Journal of Infectious Diseases, 1992-03-01

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  2019-November 

Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 andGEMINI-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  2018-November

Raltegravir1200 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   2017-September

 

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 suppl_1, Fall 2017

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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

JAIDSJournal of Acquired Immune Deficiency Syndromes November 1, 2016 

Phase III b, open-label single-arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV-1-infected treatment-nave adults

Karen T. Tashima, Gordon Crofoot, Frank Tomaka, Thomas N. Kakuda, Anne Brochot

Journal of the International AIDS Society 2014-11-02