Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
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Purpose
The purpose of this study is to evaluate the efficacy of a single-tablet regimen (STR)containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment naïve adult subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV HIV Infections |
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide Drug: elvitegravir/cobicistat/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/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults |
- The proportion of subjects who have HIV-1 RNA < 50 copies/mL [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]The primary efficacy endpoint is determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48
- The proportion of subjects with HIV-RNA <20 and <200 copies/mL at Weeks 48 and 96 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]The proportion of subjects with HIV-RNA <20 and <200 copies/mL at Weeks 48 and 96 as defined by FDA snapshot analysis
- Change from Baseline in CD4+ cell count at Weeks 48 and 96 [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]The change from Baseline in CD4+ cell count at Weeks 48 and 96
| Estimated Enrollment: | 840 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Single tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir alafenamide 10 mg (E/C/F/TAF) with Placebo to match single-tablet regiment of elvitegravir 150 mg/cobicistat 150 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) for 96 weeks
|
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir alafenamide 10 mg(E/C/F/TAF) + Placebo to match single tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) administered orally QD
|
|
Active Comparator: elvitegravir/cobicistat/emtricitabine/tenofovir DF
Single-tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) QD + Placebo to match single-table regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) QD for 96 weeks
|
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) + placebo to match single tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) administered orally QD
Other Name: Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate)
|
Detailed Description:
Randomized, Double-Blind, multicenter, active-controlled study to evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in achieving HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis in HIV-1 infected subjects.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 ≥ 1,000 copies/mL at screening
- No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP), post-exposure prophylaxis (PEP), or treatment during pregnancy, up to 6 months prior to screening
- Screening genotype report must show sensitivity to EVG, FTC, TDF
- Normal electrocardiogram (ECG)
- Estimated GFR ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Male subjects and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
- 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 have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
- Age ≥ 18 years
Exclusion Criteria:
- A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive
- Subjects experiencing decompensated cirrhosis
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an 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, noninvasive cutaneous squamous carcinoma
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
- Participation in any other clinical trial (including observational trials) without prior approval
- Subjects receiving ongoing therapy with drugs not to be used with EVG, COBI, FTC, TDF, and TAF or subjects with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets
Contacts and Locations| Contact: Babi Das Wadhwani | 650-522-4237 | babi.daswadhwani@gilead.com |
Show 177 Study Locations| Study Director: | Marshall Fordyce, MD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01780506 History of Changes |
| Other Study ID Numbers: | GS-US-292-0104, 2012-004458-27 |
| Study First Received: | January 16, 2013 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
HIV Treatment Naive HIV 1 Infected Female Women |
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 |
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 May 23, 2013