Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults - Full Text View

Purpose

This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide 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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 ]
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Secondary Outcome Measures:

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48 [ Time Frame: Baseline; Weeks 24 and 48 ]
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 [ Time Frame: Baseline; Weeks 24 and 48 ]


Enrollment:	279
Study Start Date:	December 2011
Study Completion Date:	August 2016
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: E/C/F/TAF E/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks	Drug: E/C/F/TAF E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily Other Name: Genvoya® Drug: E/C/F/TDF Placebo E/C/F/TDF placebo tablet administered orally once daily
Active Comparator: E/C/F/TDF E/C/F/TDF plus E/C/F/TAF placebo for at least 48 weeks	Drug: E/C/F/TDF E/C/F/TDF (150/150/200/300 mg) FDC tablet administered orally once daily Other Name: Stribild® Drug: E/C/F/TAF Placebo E/C/F/TAF placebo tablet administered orally once daily
Experimental: E/C/F/TAF Open-Label Following study unblinding, participants from the E/C/F/TAF and E/C/F/TDF arms may have the option to receive E/C/F/TAF during an open-label extension phase. Also, participants who are actively participating in a Gilead-sponsored study of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate and receive E/C/F/TAF in this open-label extension phase.	Drug: E/C/F/TAF E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily Other Name: Genvoya®

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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 FDC 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

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: NCT01497899

Show 43 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators


Study Director:	Devi SenGupta, MD	Gilead Sciences

More Information

Publications:

Sax PE, Zolopa A, Brar I, Elion R, Ortiz R, Post F, Wang H, Callebaut C, Martin H, Fordyce MW, McCallister S. Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):52-8. doi: 10.1097/QAI.0000000000000225.


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
Results First Received:	December 4, 2015
Last Updated:	September 8, 2016

Keywords provided by Gilead Sciences:


HIV-1 HIV Treatment-Naive

Additional relevant MeSH terms:


HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Tenofovir	Cobicistat Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2017