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: June 10, 2014
Last verified: June 2014

December 14, 2011
June 10, 2014
December 2011
October 2012   (final data collection date for primary outcome measure)
Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Percentage of subjects with HIV 1 RNA < 50 copies/mL at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the percentage of subjects with HIV 1 RNA < 50 copies/mL at Week 24
Complete list of historical versions of study NCT01497899 on ClinicalTrials.gov Archive Site
  • 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.
Percentage of subjects with HIV 1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
The percentage of subjects with HIV 1 RNA < 50 copies/mL at Week 48
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Drug: E/C/F/TAF
    Elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/GS-7340 10mg STR administered orally once daily
  • 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
  • Drug: Placebo to match E/C/F/TDF
    Placebo to match E/C/F/TDF administered orally once daily
  • Experimental: E/C/F/TAF
    Participants will receive E/C/F/TAF plus placebo to match E/C/F/TDF.
    Interventions:
    • Drug: E/C/F/TAF
    • Drug: Placebo to match E/C/F/TDF
  • Active Comparator: E/C/F/TDF
    Participants will receive E/C/F/TDF plus placebo to match E/C/F/TAF.
    Interventions:
    • Drug: E/C/F/TDF
    • Drug: Placebo to match E/C/F/TAF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2015
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01497899
GS-US-292-0102
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Hal Martin, MD Gilead Sciences
Gilead Sciences
June 2014

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