Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults - Full Text View

Sponsor:	Gilead Sciences
Information provided by (Responsible Party):	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01095796

Purpose

To evaluate the safety and efficacy of a single tablet regimen containing fixed doses of EVG/FTC/TDF/GS-9350 versus Atripla in HIV-1 infected, antiretroviral treatment-naive adults. This new tablet of EVG/FTC/TDF/GS-9350 could offer an alternative fixed-dose regimen for patients who cannot tolerate Atripla or are women of childbearing potential (due to the teratogenicity concerns of efavirenz, a component of Atripla).

Condition	Intervention	Phase
HIV HIV Infections	Drug: elvitegravir /emtricitabine /tenofovir DF /GS-9350 Drug: efavirenz /emtricitabine /tenofovir disoproxil fumarate	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Efavirenz Tenofovir Disoproxil Fumarate Atripla

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

The primary efficacy endpoint is the proportion of subjects achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL through Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL through Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
The proportion of subjects with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
The change from baseline in CD4+ cell count at Weeks 48 and 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Enrollment:	700
Study Start Date:	March 2010
Estimated Study Completion Date:	October 2012
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: elvitegravir /emtricitabine /tenofovir DF /GS-9350 Fixed-dose combination tablet of EVG/FTC/TDF/GS‑9350 QD + Placebo to match the fixed-dose combination tablet of Atripla QHS (n = 350)	Drug: elvitegravir /emtricitabine /tenofovir DF /GS-9350 Fixed-dose combination tablet of elvitegravir 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg/GS-9350 150 mg QD + Placebo to match fixed-dose combination tablet of efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg QHS (n = 350)
Active Comparator: efavirenz /emtricitabine /tenofovir disoproxil fumarate Atripla QHS + Placebo to match the fixed-dose combination tablet of EVG/FTC/TDF/GS‑9350 QD (n = 350)	Drug: efavirenz /emtricitabine /tenofovir disoproxil fumarate Fixed-dose combination tablet of efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg QHS + Placebo to match fixed-dose combination tablet of elvitegravir 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg/GS-9350 150 mg QD (n = 350) Other Name: Atripla

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, which must be obtained prior to initiation of study procedures
Plasma HIV-1 RNA levels greater than or equal to greater than or equal to 5,000 copies/mL
No prior use of any approved or investigational antiretroviral drug for any length of time
Screening genotype report must show sensitivity to FTC, TDF and EFV
Normal ECG
Adequate renal function
Hepatic transaminases (AST and ALT) less than or equal to 5 x ULN
Total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase less than or equal to 5 x ULN
Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug
Age ≥ 18 years
Life expectancy ≥ 1 year

Exclusion Criteria:

New AIDS defining condition diagnosed within the 30 days prior to screening
Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
Subjects experiencing cirrhosis
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Implanted defibrillator or pacemaker
Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
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
Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
Medications contraindicated for use with elvitegravir (EVG), GS-9350, emtricitabine (FTC), efavirenz (EFV), or tenofovir disoproxil fumarate (TDF); or subjects with any known allergies to the excipients of EVG/FTC/TDF/GS-9350 fixed-dose combination tablets or and Atripla tablets (EFV/FTC/TDF or ATR)
Participation in any other clinical trial without prior approval
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: NCT01095796

Show 115 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Erin Quirk, MD

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01095796 History of Changes
Other Study ID Numbers:	GS-US-236-0102
Study First Received:	March 17, 2010
Last Updated:	October 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Treatment Naive
HIV 1 Infected

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir disoproxil
Tenofovir

Efavirenz
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
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 May 23, 2012