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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

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ClinicalTrials.gov Identifier: NCT01286740
Recruitment Status : Completed
First Posted : January 31, 2011
Results First Posted : April 19, 2013
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 27, 2011
First Posted Date  ICMJE January 31, 2011
Results First Submitted Date  ICMJE March 8, 2013
Results First Posted Date  ICMJE April 19, 2013
Last Update Posted Date April 26, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis) [ Time Frame: Week 12 ]
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
The primary efficacy endpoint is the proportion of subjects who have HIV-1 RNA < 50 copies/mL at Week 12 [ Time Frame: 12 Weeks ]
Change History Complete list of historical versions of study NCT01286740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis) [ Time Frame: Week 24 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
The secondary endpoint is to evaluate the safety and tolerability of FTC/RPV/TDF STR over 48 weeks [ Time Frame: 48 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: FTC/RPV/TDF
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Intervention: Drug: FTC/RPV/TDF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01286740
Other Study ID Numbers  ICMJE GS-US-264-0111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Pugatch, MD Gilead Sciences
PRS Account Gilead Sciences
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP