Trial record 2 of 27 for:    " December 14, 2011":" January 13, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV 1 Infected, Antiretroviral Treatment-Naive Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01497899
First received: December 14, 2011
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

This study is to evaluate the safety, efficacy, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen (STR) versus E/C/F/tenofovir disoproxil fumarate (TDF; E/C/F/TDF) STR in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections
Drug: E/C/F/TAF
Drug: E/C/F/TDF
Drug: Placebo to match E/C/F/TAF
Drug: Placebo to match E/C/F/TDF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV 1 Infected, Antiretroviral Treatment-Naive Adults

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 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Change from baseline in log10 HIV-1 RNA and in CD4+ cell count at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Percentage of participants switching from a cobicistat-boosted darunavir regimen that remain suppressed at Week 48 of the open-label extension phase [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Participants who are actively participating in a Gilead-sponsored trial of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors(NRTIs) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate in the open-label extension phase of E/C/F/TAF.


Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E/C/F/TAF
Participants will receive E/C/F/TAF plus placebo to match E/C/F/TDF.
Drug: E/C/F/TAF
Elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/GS-7340 10mg STR administered orally once daily
Drug: Placebo to match E/C/F/TDF
Placebo to match E/C/F/TDF administered orally once daily
Active Comparator: E/C/F/TDF
Participants will receive E/C/F/TDF plus placebo to match E/C/F/TAF.
Drug: E/C/F/TDF
Elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/ tenofovir disoproxil fumarate 300 mg STR administered orally once daily
Drug: Placebo to match E/C/F/TAF
Placebo to match E/C/F/TAF administered orally once daily

  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
  • Plasma HIV 1 RNA levels ≥ 5,000 copies/mL
  • No prior use of any approved or experimental anti-HIV drug for any length of time
  • Screening genotype report must show sensitivity to TDF and emtricitabine (FTC)
  • Normal ECG
  • Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
  • Hepatic transaminases ≤ 2.5 x upper limit of the normal range (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • CD4+ cell count > 50 cells/µL
  • Serum amylase ≤ 5 x ULN
  • Normal thyroid-stimulating hormone (TSH)
  • Females of childbearing potential must have a negative serum pregnancy test
  • Females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drugs
  • 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
  • Female subjects who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and hormonal failure
  • Female subjects who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level test at screening
  • Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 90 days following discontinuation of investigational medicinal product
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Exclusion Criteria:

  • New AIDS-defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface Antigen positive
  • Hepatitis C Antibody positive
  • Proven acute hepatitis in the 30 days prior to study entry
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir and cobicistat
  • 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
  • Current alcohol or substance
  • History of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma or resected, non-invasive cutaneous squamous carcinoma
  • Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
  • Participation in any other clinical trial without prior approval is prohibited while participating in this trial
  • Medications contraindicated for use with emtricitabine or tenofovir disoproxil fumarate
  • Any known allergies to the excipients of E/C/F/TAF or E/C/F/TDF STR tablets
  • 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: NCT01497899

  Show 42 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Hal Martin, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01497899     History of Changes
Other Study ID Numbers: GS-US-292-0102
Study First Received: December 14, 2011
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

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

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
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
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 17, 2014