AzTrials
AzTrials

HIV-1 InfectionPhase 3NCT01252940

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

A Phase 3 study testing FTC/RPV/TDF, PI and RTV in people with HIV-1 Infection, run by Gilead Sciences at 111 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
FTC/RPV/TDF, PI and RTV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
482 participants
Where
111 sitesin 10 countries
Study dates
Nov 2010to Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and sign a written informed consent form
  • Receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIs continuously for ≥ 6 months preceding the screening visit
  • Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 6 months prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screening visit
  • On their first or second antiretroviral drug regimen; if on their second regimen, HIV-1 RNA ≤ 50 copies/mL required at the time of the first change in antiretroviral drugs, and no HIV RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA < 50 copies/mL
  • No previous use of any approved or experimental nonnucleoside reverse transcriptase inhibitor (NNRTI) drug for any length of time
  • Have a genotype prior to starting initial antiretroviral therapy and no known resistance to any of the study agents
Show all 15Show fewer
  • Normal ECG
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
  • Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN eligible if serum lipase ≤ 5 x ULN)
  • Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula)
  • Males and females of childbearing potential must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must have been an effective barrier method, or been nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 30 days following the last dose of study drug.
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Who cannot join

  • A new AIDS-defining condition diagnosed within 30 days prior to screening except cluster of differentiation 4 (CD4) cell count and/or percentage criteria
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Proven or suspected acute hepatitis 30 days prior to study entry.
  • Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
  • History of malignancy within 5 years prior to study entry or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Show all 14Show fewer
  • Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Anticipated need to initiate contraindicated drugs during the study, including drugs not to be used with FTC, TDF, RPV; or subjects with known allergies to the excipients of FTC/RPV/TDF STR tablets or Truvada® tablets
  • All investigational drugs
  • Medications and use of herbal/natural supplements excluded or to be used with caution while participating in the study, including those not to be taken with Viread®, Emtriva®, Truvada, and Rilpivirine.
  • Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial
  • Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
  • History of liver disease, including Gilbert's Disease
  • Any other clinical condition or prior therapy making the subject unsuitable for the study or unable to comply with the dosing requirements

Trial locations and contacts

111 sites in 10 countries.

111 sites in 10 countries

United States66 sites

  • Clinical Alliance for Research & Education-Infectious Diseases, LLC (CARE-ID)

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Atlanta ID Group

    Atlanta, Georgia, 30309

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AIDS Healthcare Foundation-Research Center

    Beverly Hills, California, 90211

  • Pacific Oaks Medical Group

    Beverly Hills, California

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • ID Consultant, P.A.

    Charlotte, North Carolina, 28209

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Northstar Medical Center

    Chicago, Illinois, 60657

  • University of South Carolina

    Columbia, South Carolina, 29203

  • Center for Special Immunology

    Costa Mesa, California, 92626

  • Nicholaos Bellos, MD, PA

    Dallas, Texas, 75204

  • Infectious Disease Specialists of Atlanta (IDSA)

    Decatur, Georgia, 30033

  • Gary Richmond, MD, PA, Inc.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Diseases Associates

    Fort Worth, Texas, 76104

  • Midway Immunology & Research Center

    Ft. Pierce, Florida, 34982

  • Garcia Family Medical Clinic

    Harlingen, Texas, 78550

  • Kaiser Permanente

    Hayward, California, 94545

  • Therapeutic Concepts, P.A.

    Houston, Texas, 77004

  • Gordon E. Crofoot, MD, PA

    Houston, Texas, 77098

  • Research Access Network

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Kansas City Free Health Clinic

    Kansas City, Missouri

  • Health for Life Clinic, PLLC

    Little Rock, Arkansas, 72207

  • The Living Hope Foundation

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90019

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Jeffrey Goodman Special Care Clinic

    Los Angeles, California, 90028

  • Oasis Clinic

    Los Angeles, California, 90059

  • Anthony Mills, MD Internal Medicine

    Los Angeles, California, 90069

  • Johns Hopkins University School of Medicine

    Lutherville, Maryland, 21093

  • The Kinder Medical Group

    Miami, Florida, 33133

  • Care Resource

    Miami, Florida

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Greiger Clinic

    Mount Vernon, New York

  • Beth Israel Medical Center

    New York, New York, 10003

  • The Aaron Diamond AIDS Research Center

    New York, New York, 10016

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • Alameda County Medical Center

    Oakland, California, 94602

  • East Bay AIDS Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • ValueHealthMD, LLC/IDOCF

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94303

  • Wade, Barbara Private Practice

    Pensacola, Florida, 32504

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • University of California, Davis

    Sacramento, California, 95187

  • Kaiser Permanente

    Sacramento, California, 95825

  • Barry M. Rodwick, M.D.

    Safety Harbor, Florida, 34695

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Metropolis Medical

    San Francisco, California, 94115

  • Kaiser Permanente

    San Francisco, California, 94118

  • South Jersey Infectious Disease

    Somer Point, New Jersey, 08244

  • The Research Institute

    Springfield, Massachusetts, 01105

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • University of South Florida - HIV Clinical Research Unit

    Tampa, Florida, 33062

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33614

  • Capital Medical Associates PC

    Washington D.C., District of Columbia, 20036

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

France9 sites

  • Hôpital Hôtel-Dieu

    Lyon, 69002

  • Infectiologie - 7ème Ouest - CHU HOTEL DIEU

    Nantes

  • Archet 1 CHU de Nice - 6ème Niveau - Infectiology

    Nice, 06202

  • Department of Infectious Diseases, Saint-Louis hospital

    Paris, 75010

  • Hôpital Saint Antoine, Servuce de Maladies Infectieuses

    Paris, 75012

  • Bichat Hospital

    Paris, 75018

  • Hopital Tenon

    Paris

  • Maladies Infectieuses Dpt

    Paris

  • Hôpital Haut Levêque

    Pessac

Other trials in France

Germany7 sites

  • EPIMED GmbH

    Berlin, 12157

  • University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic

    Bonn, 53127

  • University of Cologne, Department of Internal Medicine

    Cologne, 50937

  • Center for HIV and Hepatogastroenterology

    Düsseldorf

  • Infectio Research

    Frankfurt, 60596

  • ICH Study Center Hamburg

    Hamburg, 20146

  • University Medical Center Hamburg - Eppendorf

    Hamburg

Other trials in Germany

United Kingdom6 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, East Sussex, BN2 1ES

  • Barts and the London NHS Trust

    London, E1 1BB

  • Royal Free Hospital

    London, NW3 2QG

  • Chelsea and Westminster Hospital Foundation Trust

    London, SW10 9NH

  • Homerton Unversity Hospital

    London

  • North Manchester General Hospital

    Manchester, M85RB

Other trials in United Kingdom

Austria5 sites

  • Univ.-Kklinik fuer Innere Medizin III

    Salzberg

  • LKH Graz West

    Styria

  • 2.Interne Lungenabteilung Otto Wagner Spital

    Vienna

  • Dept. of Dermatology, Div. of Immunology,

    Vienna

  • Private Office

    Vienna

Other trials in Austria

Canada5 sites

  • Clinique Medicale Du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • Maple Leaf Research

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Downtown Infectious Disease Clinic - Univ of BC

    Vancouver, British Columbia

  • Winnipeg Regional Health Authority

    Winnipeg

Other trials in Canada

Italy5 sites

  • Ospedali Riuniti

    Bergamo, 24128

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20127

  • Azienda Ospedaliera San Paolo, Mallattie Infettive e Tropicali

    Milan, 20142

  • Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

    Milan, 20157

  • National Institute for Infectious Diseases "L. Spallanzani" IRCCS

    Rome, 20149

Other trials in Italy

Spain4 sites

  • Hospital Clinic i Provincial

    Barcelona, 28036

  • Hospital Germans Trias i Pujol

    Barcelona, 28916

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Ramon y Cajal

    Madrid, 28034

Other trials in Spain

Belgium3 sites

  • CHU Saint-Pierre University Hospital

    Brussels, 1000

  • University Hospitals Leuven

    Flemish Brabant

  • Universitaire Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

Puerto Rico1 site

  • Clinical Research Puerto Rico, Inc.

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients

The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment.

Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.

After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

Conditions
HIV-1 Infection
Being tested
FTC/RPV/TDF, PI, RTV, NRTIs
Keywords
HIV-1, HIV, Treatment Experienced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FTC/RPV/TDFDrug

    Also called Complera®, Eviplera®

    Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily (QD)

  • PIDrug

    Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information.

  • RTVDrug

    Ritonavir (RTV) was administered according to prescribing information.

  • NRTIsDrug

    NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF, Truvada® (emtricitabine/tenofovir DF, coformulated), and zidovudine. NRTIs were administered according to prescribing information.

Study groups in NCT01252940
Study groupRoleWhat they receive
FTC/RPV/TDFExperimentalParticipants will switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
Receives: Drug: FTC/RPV/TDF
SBR/Delayed SwitchExperimentalParticipants will stay on baseline regimen (SBR; their existing treatment regimen of PI+RTV plus 2 NRTIs) at the beginning of the study through Week 24, and may switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Receives: Drug: FTC/RPV/TDF; Drug: PI; Drug: RTV; Drug: NRTIs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.

    Measured: Week 24

Secondary outcomes (11)

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.

    By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

    Measured: Week 48

  2. Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24

    The mean (SD) change in CD4 count was analyzed from baseline through Week 24.

    Measured: Baseline to Week 24

  3. Change From Baseline in CD4 Count Through Week 48

    The mean (SD) change in CD4 count was analyzed from baseline through Week 48.

    By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

    Measured: Baseline to Week 48

  4. Change From Baseline in Fasting Total Cholesterol Through Week 24

    The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.

    Measured: Baseline to Week 24

  5. Change From Baseline in Fasting Total Cholesterol Through Week 48

    The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed.

    By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

    Measured: Baseline to Week 48

  6. Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24

    The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.

    Measured: Baseline to Week 24

  7. Change From Baseline in Fasting HDL Cholesterol Through Week 48

    The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed.

    By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

    Measured: Baseline to Week 48

  8. Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24

    The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.

    Measured: Baseline to Week 24

  9. Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48

    The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed.

    By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

    Measured: Baseline to Week 48

  10. Change From Baseline in Fasting Triglycerides Through Week 24

    The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.

    Measured: Baseline to Week 24

  11. Change From Baseline in Fasting Triglycerides Through Week 48

    The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed.

    By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

    Measured: Baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 2012
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
482 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01252940
Sponsor's protocol ID
GS-US-264-0106
Other IDs
2010-023178-37
Status last verified
Oct 2015
First submitted
1 Dec 2010
Last updated
4 Dec 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FTC/RPV/TDF, PI and RTV in people with HIV-1 Infection, run by Gilead Sciences at 111 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, France, Germany, United Kingdom, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01252940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in