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 - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Tenofovir Disoproxil Fumarate Elvitegravir Cobicistat

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 ] [ 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

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 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:	December 5, 2014
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 Immune System Diseases Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Emtricitabine	Tenofovir Tenofovir disoproxil Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015