Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
This study is not yet open for participant recruitment.
Verified March 2013 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01815736
First received: March 19, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
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Purpose
The purpose of this study is to evaluate the non-inferiority of switching to a TAF-Containing Combination single tablet regimen (STR) relative to maintaining TDF-containing combination regimens in virologically-suppressed HIV-1 positive subjects as determined by having HIV-1 RNA < 50 copies/mL at Week 48 following the switch.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV HIV Infections |
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide Drug: E/C/F/TDF, EFV/FTC/TDF, ritonavir + atazanavir + FTC/TDF, or GS-9350 + atazanavir + FTC/TDF |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Open-Label Study to Evaluate Switching From a TDF-containing Combination Regimens to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-suppressed, HIV-1 Positive Subjects |
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
Ritonavir
Atazanavir
Tenofovir Disoproxil Fumarate
Atazanavir sulfate
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- To determine the safety by the percent change from baseline in hip and spine bone mineral density [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]To determine the safety of the two treatment regimens as determined by the percent change from baseline in hip and spine bone mineral density at Week 48
- To determine the safety determined by the change from baseline in serum creatinine at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]To determine the safety of the two treatment regimens as determined by the change from baseline in serum creatinine at Week 48
| Estimated Enrollment: | 1500 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Switch to single-tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir alafenamide 10 mg (E/C/F/TAF STR) for 48 weeks
|
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide |
|
Active Comparator: E/C/F/TDF, EFV/FTC/TDF, ATV/r+FTC/TDF or ATV/co+FTC/TDF
Maintain pre-existing regimen (E/C/F/TDF, EFV/FTC/TDF, ATV/r + FTC/TDF or ATV/co + FTC/TDF) for 48 weeks
|
Drug: E/C/F/TDF, EFV/FTC/TDF, ritonavir + atazanavir + FTC/TDF, or GS-9350 + atazanavir + FTC/TDF
Other Names:
|
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
- Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, ATV/r + FTC/TDF, or ATV/co + FTC/TDF for ≥ 6 consecutive months preceding the final visit in their earlier study
- Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only subjects on an efavirenz-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105
- Plasma HIV-1 RNA concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA <50 copies/mL at the screening visit
- Normal echocardiograph (ECG)
- Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- 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 AIDS-defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen position
- 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 without prior approval from the sponsor is prohibited while participating in this trial
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815736
Show 182 Study Locations
Contacts
| Contact: Cecilia Tran-Muchowski | (650) 372-7383 | Cecilia.Tran-Muchowski@gilead.com |
Show 182 Study LocationsSponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Scott McAllister, MD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01815736 History of Changes |
| Other Study ID Numbers: | GS-US-292-0109, 2012-005114-20 |
| Study First Received: | March 19, 2013 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
HIV HIV 1 Infected Virologically-Suppressed |
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 Ritonavir Atazanavir Tenofovir |
Tenofovir disoproxil Emtricitabine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013