Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01495702 |
Recruitment Status
:
Completed
First Posted
: December 20, 2011
Results First Posted
: January 26, 2015
Last Update Posted
: January 7, 2016
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acquired Immunodeficiency Syndrome HIV Infections | Drug: NNRTI Drug: FTC/TDF Drug: Stribild | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 439 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Stribild
Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase.
|
Drug: Stribild
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
|
Active Comparator: NNRTI+FTC/TDF
Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
|
Drug: NNRTI
NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.
Drug: FTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information
Other Name: Truvada
Drug: Stribild
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 [ Time Frame: Week 96 ]The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
- Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
- Change From Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline; Week 96 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability to understand and sign a written informed consent form
- Be stable on the current formulation(s) of an antiretroviral regimen consisting of an NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes those who began a regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs.
- Be on the first or second antiretroviral regimen with documented undetectable plasma HIV 1 RNA levels for ≥ 6 months preceding the screening visit
- No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time
- Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC
- HIV RNA < 50 copies/mL at screening
- Normal ECG
- Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)
- Total bilirubin ≤ 1.5 mg/dL
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Estimated glomerular filtration rate ≥ 70 mL/min
- Females of childbearing potential must agree to utilize protocol recommended contraception methods or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants following the last dose of study drug
- Female participants 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
- Male participants must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse or be nonheterosexually active, and practice sexual abstinence from the screening visit.
- Age ≥ 18 years
Exclusion Criteria:
- New AIDS-defining condition diagnosed within the 30 days prior to screening
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Receiving drug treatment for hepatitis C, or those who are anticipated to receive treatment for hepatitis C during the course of the study
- Experiencing decompensated cirrhosis
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance abuse that would interfere with compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and must not be anticipated to require systemic therapy during the study.
- Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- 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
- Receiving ongoing therapy with any of the medications, including drugs not to be used with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the excipients of E/C/F/TDF tablets, or FTC/TDF tablets
- No anticipated need to initiate drugs during the study that are contraindicated
- Receiving other investigational drugs
- Participation in any other clinical trial
- Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495702

Study Director: | Damian McColl | Gilead Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01495702 History of Changes |
Other Study ID Numbers: |
GS-US-236-0121 2011-004963-56 ( EudraCT Number ) |
First Posted: | December 20, 2011 Key Record Dates |
Results First Posted: | January 26, 2015 |
Last Update Posted: | January 7, 2016 |
Last Verified: | December 2015 |
Keywords provided by Gilead Sciences:
HIV-1 HIV Treatment Experienced |
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 Emtricitabine |
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Cobicistat Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Reverse Transcriptase Inhibitors Antiviral Agents Anti-Infective Agents 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 |