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Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: FTC/RPV/TAF (Drug); Placebo to match EFV/FTC/TDF (Drug); EFV/FTC/TDF (Drug); Placebo to match FTC/RPV/TAF (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Huyen Cao, MD, Study Director, Affiliation: Gilead Sciences

Overall contact:
Gilead Study Team, Email: GS-US-366-1160@gilead.com

Summary

This study will evaluate the efficacy and safety of emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) versus continuing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in HIV-1 infected adults who have been virologically suppressed (HIV 1 RNA < 50 copies/mL) on a stable regimen of EFV/FTC/TDF FDC for ≥ 6 consecutive months at screening.

Clinical Details

Official title: A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot algorithm

Secondary outcome:

Change from baseline in CD4+ cell count

Percent change from baseline in hip and spine bone mineral density (BMD)

Change from baseline in HIV symptom index score

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The ability to understand and sign a written informed consent form, which must be

obtained prior to initiation of study procedures

- Currently receiving EFV/FTC/TDF FDC for 6 consecutive months preceding the screening

visit

- Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level

according to the local assay being used if the limit of detection is > 50 copies/mL) for 6 months preceding the screening visit. Unconfirmed virologic elevation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable

- Have no documented resistance to any of the study agents at any time in the past

- HIV-1 RNA < 50 copies/mL at the screening visit

- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)

- Total bilirubin ≤ 1. 5 mg/dL, or normal direct bilirubin

- Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets

≥50,000/mm^3; hemoglobin ≥ 8. 5 g/dL)

- Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain

eligible if serum lipase is ≤ 5 × ULN)

- Normal ECG (or if abnormal, determined by the Investigator to be not clinically

significant)

- Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min according

to the Cockcroft-Gault formula Exclusion Criteria:

- Hepatitis B surface antigen (HBsAg) positive

- Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA

(individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll)

- Individuals experiencing or with a medical history of decompensated cirrhosis (e. g.,

ascites, encephalopathy, etc.)

- Females who are breastfeeding

- Positive serum pregnancy test

- Current alcohol or substance use judged by the Investigator to potentially interfere

with the individual's study compliance

- A history of malignancy within the past 5 years (prior to screening) or ongoing

malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline/Day 1 and must not be anticipated to require systemic therapy during the study

- Active, serious infections (other than HIV-1 infection) requiring parenteral

antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1

- Any other clinical condition or prior therapy that, in the opinion of the

Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements

- Participation in any other clinical trial (including observational trials) without

prior approval from the sponsor is prohibited while participating in this trial

- Individuals receiving ongoing therapy with any of the following medications in the

table below, including drugs not to be used with FTC, RPV and/or TAF (refer to the individual agents Prescribing Information); or individuals with any known allergies to the excipients of FTC/RPV/TAF

Locations and Contacts

Gilead Study Team, Email: GS-US-366-1160@gilead.com

CHU Saint-Pierre University Hospital, Brussels, Belgium; Recruiting

Cliniques Universitaires UCL Saint-Luc, Brussels, Belgium; Not yet recruiting

Hopital Henri Mondor, Creteil, France; Not yet recruiting

Hôpital de la Croix Rousse, Lyon, France; Not yet recruiting

HEGP - Service Immunologie Clinique, Paris, France; Not yet recruiting

Hopital Bichat Claude Bernard, Paris, France; Not yet recruiting

Hopital Saint Antoine, Paris, France; Not yet recruiting

Hopital Saint Louis, Paris, France; Not yet recruiting

Chu Tours, Tours, France; Not yet recruiting

MIB Dienstleistung GmbH, Berlin, Germany; Recruiting

University of Bonn, Bonn, Germany; Recruiting

Universitätsklinikum Essen, Essen, Germany; Recruiting

Infektiologikum, Frankfurt, Germany; Recruiting

ICH Study Center Hamburg, Hamburg, Germany; Recruiting

Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany; Recruiting

Universitat zu Koln, Koln, Germany; Recruiting

MUC Research GmbH, München, Germany; Recruiting

Fondazione IRCCS San Raffaele del Monte Tabor, Milano, Italy; Withdrawn

Ospedale Luigi Sacco, Milano, Italy; Withdrawn

Azienda Ospedaliera Policlinico di Modena, Modena, Italy; Withdrawn

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S., Roma, Italy; Withdrawn

Policlinico Universitario Agostino Gemelli, Rome, Italy; Withdrawn

Amedeo di Savoia Hospital, Torino, Italy; Withdrawn

Hagaziekenhuis, Den Haag, Netherlands; Not yet recruiting

Clinical Research Puerto Rico Inc, San Juan, Puerto Rico; Recruiting

Hope Clinical Research, San Juan, Puerto Rico; Recruiting

University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Recruiting

Hospital General Universitario de Alicante, Alicante, Spain; Not yet recruiting

Hospital Clinic i Provincial, Barcelona, Spain; Recruiting

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Not yet recruiting

Hospital del Mar, Barcelona, Spain; Recruiting

Hospital Universitary de Bellvitge, Barcelona, Spain; Recruiting

Hospital Vall d'Hebron, Barcelona, Spain; Not yet recruiting

Hospital Reina Sofia, Cordoba, Spain; Not yet recruiting

Hospital Clínico Universitario San Carlos, Madrid, Spain; Not yet recruiting

Hospital Ramón y Cajal, Madrid, Spain; Not yet recruiting

Hospital Universitario 12 de Octubre, Madrid, Spain; Recruiting

Hospital Universitario La Paz, Madrid, Spain; Recruiting

Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela, Spain; Not yet recruiting

Complexo Hospitalario Xeral Cies, Vigo, Spain; Not yet recruiting

University Hospital Basel, Basel, Switzerland; Recruiting

Geneva University Hospital, Genève, Switzerland; Recruiting

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Recruiting

Heart Of England NHS Foundation Trust, Birmingham, United Kingdom; Recruiting

Barts & The London NHS Trust, London, United Kingdom; Recruiting

Chelsea & Westminster Hospital, London, United Kingdom; Recruiting

Imperial College St Mary's Hospital, London, United Kingdom; Withdrawn

King's College Hospital, London, United Kingdom; Recruiting

Mortimer Market Centre, London, United Kingdom; Recruiting

St. George's Hospital, London, United Kingdom; Not yet recruiting

The Royal Free Hampstead NHS Trust, London, United Kingdom; Recruiting

Manchester Centre for Sexual Health, Manchester, United Kingdom; Recruiting

University of Alberta, Edmonton, Alberta, Canada; Recruiting

Maricopa Integrated Health System, Phoenix, Arizona 85004, United States; Not yet recruiting

Spectrum Medical Group, Phoenix, Arizona, United States; Recruiting

Spectrum Health, Vancouver, British Columbia, Canada; Recruiting

AHF Research Center, Beverly HIlls, California, United States; Recruiting

Pacific Oaks Medical Group, Beverly Hills, California, United States; Recruiting

Long Beach Education and Research Consultants, Long Beach, California, United States; Recruiting

Kaiser Permanente, Los Angeles, California, United States; Recruiting

Peter J Ruane MD Inc, Los Angeles, California, United States; Recruiting

Southern California Men's Medical Group, Los Angeles, California, United States; Recruiting

East Bay AIDS Center, Oakland, California, United States; Not yet recruiting

Kaiser Permanente, Sacramento, California, United States; Recruiting

University of California-UC Davis, Sacramento, California, United States; Recruiting

La Playa Medical Group and Clinical Research, San Diego, California, United States; Recruiting

Kaiser Permanente, San Francisco, California, United States; Recruiting

Optimus Medical, San Francisco, California, United States; Recruiting

Kaiser Permanente, San Leandro, California, United States; Recruiting

Los Angeles BioMedical Institute at Harbor-UCLA Medical Center, Torrance, California, United States; Recruiting

University of Colorado, Aurora, Colorado, United States; Recruiting

Apex Research Institute, Denver, Colorado, United States; Recruiting

Infectious Diseases Consultants of Greenwich, Greenwich, Connecticut, United States; Not yet recruiting

Yale University School of Medicine, New Haven, Connecticut, United States; Recruiting

World Health Clinicians' CIRCLE CARE Center, Norwalk, Connecticut, United States; Recruiting

Capital Medical Associates, P.C., Washington, District of Columbia, United States; Recruiting

Medical Faculty Associates, Inc., Washington, District of Columbia, United States; Recruiting

Whitman Walker Clinic, Washington, District of Columbia, United States; Recruiting

The George Washington University Medical Center, Washinton, District of Columbia, United States; Withdrawn

Daniel A. Warner, MD, P.A., Daytona Beach, Florida, United States; Withdrawn

Gary Richmond, MD, PA, Inc., Fort Lauderdale, Florida, United States; Recruiting

Midway Immunology & Research Center, LLC, Fort Pierce, Florida, United States; Recruiting

Therafirst Medical Centers, Ft. Lauderdale, Florida, United States; Recruiting

AIDS Healthcare Foundation, Miami Beach, Florida, United States; Recruiting

AIDS Healthcare Foundation, Miami, Florida, United States; Recruiting

Coral Research Clinic Corp, Miami, Florida, United States; Recruiting

University of Miami, Miami, Florida, United States; Recruiting

Orlando Immunology Center, Orlando, Florida, United States; Recruiting

Infectious Diseases Associates of NW Florida, P.A., Pensacola, Florida, United States; Recruiting

Hillsborough County Health Dept., Tampa, Florida, United States; Recruiting

Infectious Disease Research Institute Inc., Tampa, Florida, United States; Recruiting

St. Joseph's Comprehensive Research Institute, Tampa, Florida, United States; Recruiting

AIDS Research & Treatment Center of the Treasure Coast, Vero Beach, Florida, United States; Recruiting

Triple O Research Institute, P.A., West Palm Beach, Florida, United States; Recruiting

Rowan Tree Medical PA, Wilton Manors, Florida, United States; Recruiting

AIDS Research Consortium of Atlanta, Atlanta, Georgia, United States; Recruiting

Atlanta ID Group, Atlanta, Georgia, United States; Recruiting

Kaiser Permanente, Atlanta, Georgia, United States; Not yet recruiting

Georgia Regents University Research Institute, Augusta, Georgia, United States; Not yet recruiting

Infectious Disease Specialists of Atlanta, Decatur, Georgia, United States; Recruiting

Mercer University School of Medicine, Macon, Georgia, United States; Recruiting

Chatham County Health Department, Savannah, Georgia, United States; Recruiting

Johann Wolfgang Goethe-University Hospital, Frankfurt, Hesse, Germany; Not yet recruiting

Howard Brown Health Center, Chicago, Illinois, United States; Recruiting

The CORE Foundation, Chicago, Illinois, United States; Recruiting

University of Illinois at Chicago, Chicago, Illinois, United States; Not yet recruiting

Indiana University Medical Center, Indianapolis, Indiana, United States; Recruiting

University of Louisville, Louisville, Kentucky, United States; Withdrawn

Health Sciences Centre, Winnipeg, Manitoba, Canada; Recruiting

Boston University Medical Center, Boston, Massachusetts, United States; Recruiting

Brigham and Women's, Boston, Massachusetts, United States; Recruiting

Fenway Health, Boston, Massachusetts, United States; Withdrawn

MetroWest Medical Center, Framingham, Massachusetts, United States; Recruiting

Baystate Infectious Diseases Clinical Research, Springfield, Massachusetts, United States; Recruiting

The Research Institute, Springfield, Massachusetts, United States; Recruiting

Be Well Medical Center, Berkley, Michigan, United States; Recruiting

Henry Ford Health System, Detroit, Michigan, United States; Recruiting

Newland Medical Associates, Southfield, Michigan, United States; Not yet recruiting

Hennepin County Medical Center, Minneapolis, Minnesota, United States; Recruiting

Kansas City CARE Clinic, Kansas City, Missouri, United States; Recruiting

Kansas City Free Health Clinic, Kansas City, Missouri, United States; Withdrawn

Southampton Healthcare, Inc., St Louis, Missouri, United States; Recruiting

Washington University School of Medicine, St. Louis, Missouri, United States; Not yet recruiting

New Jersey Medical School, Newark, New Jersey, United States; Not yet recruiting

Saint Michael's Medical Center, Newark, New Jersey, United States; Recruiting

South Jersey Infectious Disease, Somers Point, New Jersey, United States; Recruiting

Southwest CARE Center, Santa Fe, New Mexico, United States; Recruiting

Albany Medical College, Albany, New York, United States; Not yet recruiting

Upstate Infectious Diseases Associates, Albany, New York, United States; Recruiting

Montefiore Medical Center, Bronx, New York, United States; Recruiting

North Shore University Hospital, Manhasset, New York, United States; Recruiting

Beth Israel Medical Center, New York, New York, United States; Withdrawn

Columbia University Medical Center/ New York Presbyterian, New York, New York, United States; Recruiting

Icahn School of Medicine at Mount Sinai, New York, New York 10019, United States; Withdrawn

Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States; Recruiting

NYU School of Medicine, New York, New York, United States; Not yet recruiting

Jacobi Medical Center, South Bronx, New York, United States; Recruiting

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States; Recruiting

Infectious Disease Consultants, PA, Charlotte, North Carolina, United States; Recruiting

The Brody School of Medicine, Greenville, North Carolina, United States; Not yet recruiting

Rosedale Infectious Diseases, Huntersville, North Carolina, United States; Recruiting

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States; Not yet recruiting

Summa Health System CARE Center, Akron, Ohio, United States; Withdrawn

University of Cincinnati Med Center, Cincinnati, Ohio, United States; Not yet recruiting

The Ohio State University, Columbus, Ohio, United States; Recruiting

Maple Leaf Research, Toronto, Ontario, Canada; Recruiting

Sunnybrook Health Science Centre, Toronto, Ontario, Canada; Recruiting

University Health Network, Toronto, Ontario, Canada; Recruiting

University of Pennsylvania, Philadelphia, Pennsylvania, United States; Recruiting

Clinique medicale l'Actuel, Montreal, Quebec, Canada; Recruiting

Clinique OPUS, Montreal, Quebec, Canada; Recruiting

McGill University Health Centre, Montreal, Quebec, Canada; Recruiting

The Miriam Hospital, Providence, Rhode Island, United States; Recruiting

Medical University of South Carolina, Charleston, South Carolina, United States; Recruiting

University of South Carolina School of Medicine, Columbia, South Carolina, United States; Not yet recruiting

Central Texas Clinical Research, Central Texas Clinical Research, Texas, United States; Recruiting

North Texas Infectious Diseases Consultants, Dallas, Texas, United States; Recruiting

Southwest Infectious Disease Clinical Research, Inc., Dallas, Texas, United States; Recruiting

Trinity Health and Wellness Center/AIDS Arms, Inc., Dallas, Texas, United States; Recruiting

Tarrant County Infectious Disease Associates, Fort Worth, Texas, United States; Recruiting

Gordon E. Crofoot, MD, PA, Houston, Texas, United States; Recruiting

Research Access Network, Houston, Texas, United States; Recruiting

University of Texas, Houston, Texas, United States; Not yet recruiting

DCOL Center for Clinical Research, Longview, Texas, United States; Recruiting

Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID), Annandale, Virginia, United States; Recruiting

Peter Shalit, MD, Seattle, Washington, United States; Recruiting

Rockwood Clinic, Spokane, Washington, United States; Recruiting

Additional Information

Starting date: January 2015
Last updated: July 17, 2015

Page last updated: August 23, 2015

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