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Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01286740
First received: January 27, 2011
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.


Condition Intervention Phase
HIV-1 Infection
Drug: FTC/RPV/TDF
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2B Open Label Pilot Study to Evaluate Switching From a Regimen Consisting of a Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Single Tablet Regimen (STR) to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) STR in Virologically Suppressed, HIV 1 Infected Subjects

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.


Secondary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.

  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.

  • Plasma Concentration of RPV and EFV at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.

  • Plasma Concentration of RPV and EFV at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.

  • Plasma Concentration of RPV and EFV at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.

  • Plasma Concentration of RPV and EFV at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.

  • Plasma Concentration of RPV and EFV at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.

  • Plasma Concentration of RPV at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.

  • Plasma Concentration of EFV at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12

  • Plasma Concentration of RPV at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.

  • Plasma Concentration of RPV at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.

  • Plasma Concentration of RPV at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.


Enrollment: 50
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTC/RPV/TDF
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Drug: FTC/RPV/TDF
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily
Other Names:
  • Complera
  • Eviplera

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form
  • Receiving EFV/FTC/TDF continuously for ≥ 3 months preceding the screening visit
  • Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 8 weeks prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screening visit
  • On their first antiretroviral drug regimen, and no HIV-1 RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA < 50 copies/mL
  • Had a genotype prior to starting FTC/RPV/TDF and no known resistance to any of the study agents
  • Normal ECG
  • Hepatic transaminases (AST and ALT) ≤ 5 x 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 x ULN (subjects with serum amylase > 5 x ULN eligible if serum lipase ≤ 5 x ULN)
  • Adequate renal function (estimated glomerular filtration rate ≥ 50 mL/min according to the Cockcroft-Gault formula)
  • Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 60 days following the last dose of study drug.
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within 21 days prior to screening
  • Females who were breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Proven or suspected acute hepatitis in the 21 days prior to study entry
  • Subjects receiving drug treatment for Hepatitis C, or subjects anticipated to receive treatment for Hepatitis C during the course of the study, or with a history of liver disease
  • Was experiencing decompensated cirrhosis
  • Implanted defibrillator or pacemaker
  • Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
  • History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
  • Active, serious infections requiring parenteral antibiotic or antifungal therapy within 21 days prior to Baseline
  • All investigational drugs
  • Ongoing therapy or anticipated need to initiate drugs or herbal/natural supplements during the study that were contraindicated or not recommended for use as indicated in the protocol, including drugs not to be used with FTC, RPV, and TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF STR
  • Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial
  • Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286740

Locations
United States, California
Living Hope Clinical Foundation
Long Beach, California, United States, 90814
Anthony Mills MD, Inc.
Los Angeles, California, United States, 90069
Peter J. Ruane MD Inc
Los Angeles, California, United States, 90036
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
United States, District of Columbia
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
Dupont Circle Physicians Group, P.C.
Washington, District of Columbia, United States, 20009
Capital Medical Associates, PC
Washington, District of Columbia, United States, 20036
United States, Florida
The Kinder Medical Group
Miami, Florida, United States, 33133
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Georgia
Atlanta ID Group
Atlanta, Georgia, United States, 30309
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
United States, Illinois
Northstar Medical Center
Chicago, Illinois, United States, 60657
United States, Massachusetts
Community Research Initiative of New England
Boston, Massachusetts, United States, 02215
United States, Michigan
Be Well Medical Center, P.C.
Berkley, Michigan, United States, 48072
United States, Missouri
Southampton Healthcare, Inc.
St. Louis, Missouri, United States, 63139
United States, Texas
Southwest Infectious Disease Clinical Research, Inc.
Addison, Texas, United States, 75001
Central Texas Clinical Research
Austin, Texas, United States, 78705
United States, Washington
Peter Shalit, M.D.
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: David Pugatch, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01286740     History of Changes
Other Study ID Numbers: GS-US-264-0111
Study First Received: January 27, 2011
Results First Received: March 8, 2013
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV-1
HIV
Treatment Experienced

Additional relevant MeSH terms:
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Emtricitabine
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014