Phase 3b Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV 1 Infected Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01495702
First received: December 14, 2011
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate the non-inferiority of Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) relative to regimens consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine and Tenofovir DF (FTC/TDF) in maintaining HIV 1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV 1 infected subjects.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir df
Drug: NNRTI plus FTC/TDF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • The proportion of subjects who have HIV 1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is the proportion of subjects who have HIV 1 RNA < 50 copies/mL at Week 48


Secondary Outcome Measures:
  • To evaluate the safety and tolerability of the two regimens through Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of the two regimens through Week 96

  • To evaluate the efficacy of the two regimens through 96 weeks of treatment [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of the two regimens through 96 weeks of treatment


Estimated Enrollment: 420
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: elvitegravir/cobicistat/emtricitabine/tenofovir df
Switch to the single tablet regimen (STR) consisting of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) for 48 weeks (n = 280)
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir df
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg single tablet regimen administered orally QD with food.
Active Comparator: NNRTI plus FTC/TDF
Remain on current antiretroviral regimen consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus FTC/TDF for 48 weeks (n = 140) (Efavirenz, nevirapine, and rilpivirine are the only allowed NNRTI agents in combination with FTC/TDF, and may include the STRs: EFV/FTC/TDF or FTC/RPV/TDF).
Drug: NNRTI plus FTC/TDF

Current antiretroviral drug regimen consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus FTC/TDF administered orally.

Efavirenz, nevirapine, and rilpivirine are the only allowed NNRTI agents in combination with FTC/TDF and may include the single tablet regimens, EFV/FTC/TDF or FTC/RPV/TDF.

Other Names:
  • Truvada®
  • Atripla®

Detailed Description:

Randomized, open-label, multicenter, active-controlled study to evaluate switching from regimens consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus FTC/TDF to EVG/COBI/FTC/TDF in virologically suppressed, HIV 1 infected subjects.

  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
  • Be stable on the current formulation(s) of an antiretroviral (ARV) regimen consisting of a NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes subjects that began a regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs.
  • Be on the first of second antiretroviral regimen documented undetectable plasma HIV 1 RNA levels for ≥ 6 months preceding the screening visit
  • No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time
  • Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC
  • HIV RNA < 50 copies/mL at the screening visit
  • Normal ECG
  • Hepatic transaminases ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • Estimated glomerular filtration rate ≥ 70 mL/min
  • Females of childbearing potential must agree to utilize protocol recommended contraception methods or be non-heterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for subjects on EFV/FTC/TDF or efavirenz or 30 days for the rest of subjects following the last dose of study drug
  • Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
  • Male subjects must agree to utilize protocol recommended methods of contraception during heterosexual intercourse or be non-heterosexually active, and practice sexual abstinence from the screening visit.
  • Age ≥ 18 years

Exclusion Criteria:

  • New AIDS-defining condition diagnosed within the 30 days prior to screening
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
  • Experiencing decompensated cirrhosis
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance abuse that would interfere with compliance
  • A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study.
  • Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
  • Subjects receiving ongoing therapy with any of the medications, including drugs not to be used with EVG, COBI, FTC, TDF; or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF tablets, or FTC/TDF tablets
  • No anticipated need to initiate drugs during the study that are contraindicated
  • Receiving other investigational drugs
  • Participation in any other clinical trial
  • Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495702

  Show 80 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Thai Nguyen, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01495702     History of Changes
Other Study ID Numbers: GS-US-236-0121, 2011-004963-56
Study First Received: December 14, 2011
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Reverse Transcriptase Inhibitors
Tenofovir
Tenofovir disoproxil
Emtricitabine
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 22, 2014