CURRICULUM VITAE

SHANNON RAY SCHRADER, M.D.

 

 

PREMEDICAL EDUCATION / EXPERIENCE

 

COLLEGE:                  University of Kentucky: Lexington, Kentucky

                                    Bachelor of Science Degree - Biology, May 1984

 

MEDICAL

EDUCATION:              University of Louisville School of Medicine;

                                    Louisville, Kentucky

                                    Doctor of Medicine, May 1989

 

AWARDS:                   Kentucky Academy of Family Physicians Award - upon

                                    graduation from medical school

 

                                    RESIDENCY

 

COLLEGE:                  Baylor College of Medicine - Department of

                                    Family Medicine; Houston, Texas

                                    June 1989 - June 1992

 

                                    Chief Resident, 1991 - 1992

 

AWARDS:                   Ida and Taylor Pickett Award - upon graduation

                                    outstanding resident

 

 

PROFESSIONAL SOCIETY MEMBERSHIPS:

 

                                    American Medical Association, 1985 - present

                                    American Academy of Family Physicians, 1989 - present

                                    Texas Academy of Family Physicians, 1989 - present

                                    Texas Medical Association, 1992 - present

                                    Harris County Medical society, 1992 - present

                                    International Association of Physicians in AIDS Care

                                    American Academy of HIV Medicine, 2000 - present

 

 

VOLUNTEERING:       United Way - Big Brothers / Big Sisters Program, 1984 - 1989

                                    AIDS Foundation of Houston, 1990 - 1992

                                    Casa Juan Diego - indigent clinic for Central Americans in

                                    Houston, 1990 - 1992

 

EXAMINATIONS:         Part I and Part II - National Boards

                                    FLEX Examination / Texas Jurisprudence Examination

                                    Family Practice Certification Boards, July 1992, July 1999

 

PRACTICE:                 Solo Practitioner, Shepherd Square Family Practice Clinic

                                    July 1992 - December 1993

 

                                    Southampton Medical Group, L.C., Partner;

                                    December 1993 – December 2002

 

                                    The Schrader Clinic, PA

                                    January 2003 - Present

 

OTHER

EMPLOYMENT:          HospiCenter of Houston - Home Care Team Physician,

                                    1994 – 1996

 

                                    Body Positive Wellness Center – Medical Director

                                    1998 - present

 

                                    Thomas Street Clinic (Harris County indigent HIV clinic),

                                    1995 – 2000

 

                                    Applied Home Healthcare Hospice – Medical Director

                                    5/1998 – 5/1999

 

AVES (Amigos Volunteers in Education and Services – indigent HIV clinic for Latino persons) – Medical Director

1998 – 2001


HOSPITAL

AFFILIATIONS:            St. Luke’s Episcopal Hospital

                                    Park Plaza Hospital

                                    Methodist Hospital

 

COMMITTEES:           Baylor College of Medicine - Assistant Professor

University of Texas School of Medicine - Clinical Faculty                              Body Positive Houston - Board member, January 1997 – present

AVES – Board member, 1998 – 2001

Center for AIDS – Medical Advisory Board / Community Advisory Board

PoWeR (Program for Wellness Restoration) – Advisory Board

 

VOLUNTEERING:       Montrose Clinic - STD / HIV Clinic

                                    SEARCH – Homeless shelter – medical clinic project

 

RESEARCH:               Medical Director -     Montrose Clinic Research

                                                                        215 Westheimer

                                                                        Houston, TX 77006

 

                                                                        Montrose Clinic Research– Richmond

                                                                        3311 Richmond Ave.

                                                                        Suite 100

                                                                        Houston, TX 77098

                                                                        August 1995 - present

 

Investigator -             AmFAR Community Based Clinical Trials Network

                                                                        January 1995 - December 1997

 

Co-Investigator -      The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA):

                                    Houston AIDS Research Team (HART) – Montrose Clinic Subsite

                                    April 2000 - Present

 

STATE LICENSES:    Texas - H8386

                                    New York - 191348

                                   

 

PUBLICATIONS:         Arduino RC, Nannini E, Rodrigues-Barradas M, Schrader S, Allende M, Losso M, Ruxrungtham K, Emery S, Fosdick L, Tavel J, Davey R, Lana HC. Meta-Analysis of the CD4 Cell Response to 3 Doses of Subcutaneous Interleukin-2 (scIL-2) Across 3 Vanguard Studies.  Program & Abstracts of the 8th Conference on Retrovirus and Opportunistic Infections, February 4-8, 2001. Chicago, IL, Abstract 346.

C.Holtzer, F.M.Hecht, M.Swanson, P.Ruane, S.Schrader, C.De Guzman, D.Lapins, J.Stansell, San Francisco General Hosp., San Francisco, CA, Tower I.D., Los Angeles, CA, Southampton Med. Group, Houston, TX, Clinical Partners, San Francisco, CA. The Influence of Intensive Medication Adherence Strategies on the Clinical Outcome of HIV-Infected Patients Taking Protease Inhibitor. Abstract, 9th European Congress of Clinical Microbiology and Infectious Diseases, Berlin, Germany, 1999.

 

J.C.Gathe, C.Shapiro, S.Schrader, C.Mayberry, T.Dahl, T.Wong. Houston Clin. Res. Network, Houston, TX, Lexigen Pharm. Corp., Lexington, MA. Safety and Efficacy of FP-21399, a Novel Fusion Inhibitor: Results of a 48 Weeks Phase II Study.  Poster presentation, 6th Conference on Retroviruses and Opportunistic Infections, Chicago, IL, 1999.

 

                                    J.E.Mobley, R.Pollard, S.Schrader, M.Adler, T.Kelleher, C.McLaren, AI454-143 Team. Cooper Green Hosp., Birmingham, AL, University of Texas, Galveston, TX, Montrose Clinic, Houston, TX, Bristol-Myers Squibb, Wallingford, CT. Comparison of Once- and Twice- Daily Dosing of Didanosine in Combination with Stavudine in Treatment-Naïve Patients. Abstract, 4th International Congress on Drug Therapy in HIV Infection, Glasgow, Scotland, 1998.

 

                                    S.Schrader, B.Burkhardt, J.C.Gathe. Houston Clin. Res. Network, Houston, TX, Therapeutic Concepts, Houston, TX. Rapid Viral Load Reduction With a Regimen of Nelfinavir, Stavudine, Didanosine, and Hydroxyurea. Poster presentation, 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA, 1998.

 

                                    J.Gathe, D.F.Piot, S.Schrader, C.C.Mayberry, E.W.Stool, Therapeutic Concepts, Houston, TX, Houston Clin. Res. Net., Houston, TX. Accelerated Opportunistic Infection/Neoplasia Syndrome After HAART Initiation. Abstract 60999, 12th World AIDS Conference, Geneva, Switzerland, 1998.

 

                                    J.A.Hellinger, R.A.Torres, S.Schrader, et al. Safety and antiretroviral activity of hydroxyurea (HU) with ddI in HIV-infected individuals. Abstract I-127, 37th Interscience Conference on Antimicrobial Agent and Chemotherapy, Toronto, Ontario, 1997.

 


Served as an Investigator on

the Following Clinical

Research Protocols:

 

A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel                                          Design, Multi-Center Trial to Evaluate the Effect of Ranitidine on                                          Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects                                        with a CD4 Count Between 400 and 700 cells/mm3

 

NUCA-3002: A Randomized 3TC™, ddC, Double-Blind (ZDV Open-                                   Labeled) Multicenter Trial to Evaluate the Safety and Efficacy of                                          3TC™ (low dose) Administered Concurrently with ZDV, Versus 3TC™                          (high dose) Administered Concurrently with ZDV, Versus ddC                                       Administered Concurrently with ZDV in the Treatment of HIV-1                                          Infected, ZDV-Experienced (> 24 weeks) Patients with CD4 Cell                                                Counts of 100 to 300 cells/mm3

 

                                    3TCTM Open Label Program

 

                                    GS-93-302: A Phase I/II Study of the Safety and Efficacy of Topical                                     HPMPC in the Treatment of Condyloma Acuminatum in Patients                                                     with HIV Infection

 

GCSF-930101: A Randomized, Controlled, Multicenter Trial of                                             filgrastim (Recombinant-methionyl Human Granulocyte Colony                                           Stimulating Factor) for the Prevention of Grade 4 Neutropenia in                                     Patients with HIV Infection

 

BIPI 1062A: A Long-term Open-label Trial Assessing Safety and                                         Tolerance of Chronic Nevirapine Dosing in HIV-1 Infected Patients

 

                                    028574PR0003: A Randomized, Double-Blind Active-Controlled,                                                     Dose-Ranging Study of the Safety and Efficacy of Chronically                                                         Administered MDL 28,574A in the Treatment of HIV-Infected                                                            Patients

 

028574PR0004: A Randomized, Double-Blind Placebo-Controlled,                                     Dose-Ranging Study of the Safety and Efficacy of Chronically                                             Administered MDL 28,574A in the Treatment of HIV-Infected                                                Patients

 

 

 

 

033-02: A Multiclinic, Double-Blind, Randomized, Eighteen-Month                                       Study in HIV-1 Seropositive Patients to Compare the Efficacy and                                       Safety of MK-639, 800 mg q8h, and Zidovudine, 200 mg q8h,                                      Administered Concomitantly to MK-639 Alone and Zidovudine Alone

 

                                    AmFAR CBCTN 06: Trimethoprim Sulfamethoxazole (TMP/SMX)                                                   Desensitization Versus Direct Rechallenge In HIV-Infected Patients                                                Who Are At High Risk For Pneumocystis Carinii Pneumonia And                                                            Have Experienced A Previous Adverse Reaction To TMP/SMX

 

                                    HCRN Protocol 95-03-L1: A Pilot, Dose Ranging Study to Evaluate                                                 the Safety and Activity of Hydroxyurea in HIV Infected Patients

 

HDI-95-001: A Pilot Open Label Study to Evaluate the Safety,                                              Tolerance and Activity of Glucocorticoid, Multi-Vitamins, and Amino                                     Acid Dietary Supplement Regimen for Treating Subjects Infected                                                with the Human Immunodeficiency Virus (HIV)

 

AmFAR CBCTN 07: A Phase I/II Open-Label Study of the Safety and Antiretroviral Activity of Hydroxyurea with ddI in HIV-Infected Individuals

 

HBY 097 - 2001: A Multicenter, Randomized, Double-Blinded,                                             Dose-Escalation Study Evaluating the Safety and Antiretroviral                                            Activity of HBY 097 vs HBY 097 + AZT in Patients with                                                  Asymptomatic or Mildly Symptomatic HIV Infection

 

                                    AmFAR CBCTN 08: HIV-RNA (bDNA) Levels Following Initiation of                                      Lamivudine (3TC) in HIV-Infected Persons who are Adding 3TC to a                                               Stable Antiretroviral Regimen

 

AG1343 – 510: A Phase I/II Pilot Study of VIRACEPT™ (AG1343) in Combination with Stavudine (d4T) Versus Stavudine Alone in HIV-Positive Patients

 

AG1343 - 511: A Phase III Randomized, Double-Blind, Placebo-Controlled, Study of VIRACEPT™ in Combination with Zidovudine (AZT) + Lamivudine (3TC) Versus AZT + 3TC Alone in HIV Positive Patients with < 1 Month or No Prior Antiretroviral Treatment

 

GS-96-408: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts Between > 200/mm3

 

 

AI454-143: A Randomized, Double-Blind, Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination with Twice-Daily Dosing of Stavudine in HIV-Infected Subjects

 

CNAA/B3005: A Phase III Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy Naive Subjects

 

001.0012:  - Phase III Randomized, Double Blinded, Placebo Controlled Trial of Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (rhu GM-CSF) in Patients with Advanced HIV Disease

 

DMP 266-020: - A Phase III, Double-blind, Placebo-Controlled, Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy

 

NZTA4002: - A Comparison of a Four-drug Regimen Comprised of 141W94, Abacavir (1592U89), and Combivir™ with a Three-drug Regimen Comprised of Nelfinavir and Combivir™ in Antiretroviral-Naive, HIV-Infected Subjects

 

IL-2 Vanguard Protocol: - A Randomized, Open Label, Phase II Study of Subcutaneous Interleukin-2 (Proleukin®) Plus Antiretroviral Therapy vs. Antiretroviral Therapy Alone in Patients with HIV Infection and at Least 350 CD4+ Cells/mm3

 

Protocol 076-02 / CRX 441: - A Multicenter, Open-label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q8h Versus 1200 mg q12h, in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 copies/mL, on Concomitant Therapy with 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)

 

FIP: 98-01-01: - Phase II Trial of FP-21399 in Patients with HIV Infection On Stable Antiviral Therapy Without Complete Viral Suppression

 

DMP 266-006: - A 24-Week Phase III Multicenter, Randomized, Open-label Study To Compare Antiretroviral Activity And Tolerability Of Three Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) In HIV-Infected Patients

 

DMP 266-043: - A Phase II, Open-label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination with Stavudine and Lamivudine in Antiretroviral Therapy-Naïve HIV-Infected Patients

 

AG1036 – An Open Label Study to Assess the Safety and Antiviral Activity of a Three Drug Regimen Consisting of Nelfinavir, Stavudine and Efavirenz in HIV-Infected Patients

 

RIGHT 702 – A Phase I/II Study of the Safety and Antiretroviral Activity of Nine Hydroxyurea Regimens in Combination with ddI and d4T

 

AG1661-202 – A Randomized, Double-blind, Adjuvant-controlled, Multicenter, Study to Compare the Virologic and Immunologic Effect of Highly Active Antiretroviral Therapy (HAART) Plus REMUNE™ Versus HAART Plus Incomplete Freund’s Adjuvant (IFA) in Antiretroviral-naïve Patients Infected with Human Immunodeficiency Virus Type 1 (HIV-1)

 

FTC-301 - A Randomized, Double-Blind, Equivalence Trial Comparing Emtricitabine to Stavudine within a Triple Drug Combination Containing Didanosine Plus Efavirenz in Antiretroviral-Drug Naïve HIV-1 Infected Patients

 

EPV20001 - A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily vs Lamivudine 150mg BID in Combination with Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naïve Adults with HIV-1 Infection

 

AI424-009 – Safety and Antiviral Activity of a Novel HIV-1 Protease Inhibitor, BMS-232632 in Combination Regimen(s) as Compared to Reference Combination Regimens in Antiretroviral-experienced HIV-infected Subjects

 

ESPRIT Protocol 001 – A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 (Proleukin®) in Patients with HIV-1 Infection and CD4+ Cell Counts > 300/mm3: Evaluation of Subcutaneous Proleukin® in a Randomized International Trial (ESPRIT)

 

APV-401 – Amprenavir (Agenerase™) as a First Protease Inhibitor with Strategies for Subsequent Therapy

 

AG1549-508 – A Double-blind, Randomized, Placebo-controlled Study of AG1549 in Combination with Viracept™ and Two Nucleoside Reverse Transcriptase Inhibitors in HIV- infected Subjects Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen

 

ESS40001 – A Phase IV, Open-Label, Randomized Study to Compare the Efficacy and Safety of Epivir®/Ziagen™/Zerit® (3TC/ABC/d4T) Versus Epivir®/Ziagen™/Sustiva™ (3TC/ABC/EFV) Versus Epivir®/Ziagen™/Agenerase™/Norvir (3TC/ABC/APV/RTV) for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who are Antiretroviral Therapy Naïve

 

 

 

UMD-00-066 – A Phase III, Randomized, Double-Blind, Placebo-Controlled, Study of Oxymetholone Administered in Conjunction with Resistance Exercise and Nutritional Counseling in Adult Males with HIV-Associated Weight Loss

 

CPCRA 058 – A Randomized, Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy (HAART) Strategies in HAART-Naïve, HIV-Infected Persons

 

CPCRA 060 – A Prospective Study of Long-Term Clinical, Virologic, and Immunologic Outcomes in HIV-Infected Individuals

 

CPCRA 062 – Adherence Strategies Using a Medication Manager and an Electronic Medication Reminder System for HIV-Infected Patients Receiving HAART

 

AI424-034 – A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine

 

CPCRA 064 – A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption (STI) Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen In HIV-Infected Patients with Multidrug Resistant (MDR) Virus

 

An Open Label, Single Site Salvage Regimen Trial Comparing Crixivan/Norvir Plus Two New Nucleosides Versus Fortovase/Norvir Plus Two New Nucleosides After First Protease Inhibitor Failure

 

A Study to Assess the Long-term Antiviral Activity, Safety and Tolerability of BMS-232632 in Combination Regimens in HIV-infected Subjects Who Have Completed Participation in Clinical Studies of BMS-232632

 

AI424-043 – A Randomized, Open-Label Study of the Antiviral Efficacy and Safety of Atazanavir versus Lopinavir/Ritonavir (LPV/RTV) each in Combination With Two Nucleosides in Subjects who have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)

 

AI424-045 – A Randomized, Open-label Study Of The Antiviral Efficacy And Safety Of Atazanavir, In Combination With Ritonavir Or Saquinavir, And The Combination Of Lopinavir/Ritonavir Each With Tenofovir And A Nucleoside In Subjects Who Have Experienced Virologic Failure

 

CPCRA 065 – A Large, Simple Trial Comparing Two strategies for Management of Anti-Retroviral Therapy (The SMART Study)

 

 

 

 

ACH443-006 - A Phase 2 Trial of 4 Weeks of ACH-126,443 in Comparison With Continued Lamivudine in Stable Triple antiretroviral combination Therapy in HIV-Infected Subjects With Modestly Detectable Viral Load

 

AI455135 - A Phase IIIB, Open-Label, Randomized, Multicenter Study Switching HIV-1 Infected Subjects with a Viral Load of < 50 Copies/mL on a BID or More frequent Initial HAART Regimen to a Once Daily Regimen Including Stavudine XR, Lamivudine, and Efavirenz

 

ACH443-902 - An Open-Label Treatment Protocol to Provide Continued ACH-126,443 to Subjects of Previous Achillion-Sponsored Studies in HIV Infection

 

AI424-077 - Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

 

AI424-067 - A Phase IIIB, Open-label, Randomized, Multicenter Study Evaluating the Effect on Serum Lipids Following a Switch to the Protease Inhibitor (PI) Atazanavir in HIV-1 Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy

 

A4311006 – A Phase 2, Randomized, Double-Blind, Dose-Ranging Study of Capravirine (AG1549) in Combination with Kaletra and at Least 2 Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors

 

A4311022 - A Rollover Study for Subjects Continuing Treatment with Open-Label Capravirine Who Were Enrolled in Study A4311006

 

MDX010-10 - A Phase I Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Patients with Human Immunodeficiency Virus

 

GS-01-934 - A Phase 3, Randomized, Open-Label, Multicenter Study of the Treatment of Antiretroviral-Naïve, HIV-1-Infected Subjects Comparing Tenofovir Disproxil Fumarate and Emtricitabine in Combination with Efavirenz Versus Combivir® (lamivudine/zidovudine) and Efavirenz

 

NV17751 - Observational Cohort Study of Pneumonia in Fuzeon-exposed and Non-exposed Patients

 

AI424103 – A Phase IIIB, Open-Label, Randomized, Multi-center Study Comparing Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, each in Combination with Tenofovir and either Didanosine EC or Stavudine XR in HIV-1 Infected Subjects Receiving a NNRTI-Containing HAART Regimen who are Experiencing their First Virologic Failure

TNX-355.03 - A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Three-Arm Study of the Anti-CD4 Monoclonal Antibody TNX-355 with Optimized Background Therapy in Treatment-Experienced Subjects Infected with HIV-1

 

TMC125-C223 – A randomized, controlled, partially blinded Phase IIb dose finding trial of TMC125, in HIV-1 infected subjects with documented genotypic evidence of resistance to currently available NNRTIs and with at least three primary PI mutations

 

TMC125-C211 – An open-label trial of TMC125 in HIV-1 infected subjects who were randomized to an active control arm of any sponsor-selected TMC125 trial and either virologically failed or completed the entire treatment period