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HIV-1 InfectionPhase 3NCT01309243

Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

A Phase 3 study testing FTC/RPV/TDF and EFV/FTC/TDF in people with HIV-1 Infection, run by Gilead Sciences at 151 sites in 14 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 the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications. 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 and EFV/FTC/TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
799 participants
Where
151 sitesin 14 countries
Study dates
Feb 2011to Feb 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
  • Plasma HIV-1 RNA levels ≥ 2,500 copies/mL at screening
  • No prior use of any approved or experimental anti-HIV drug for any length of time
  • Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y
  • Normal ECG
  • Hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) ≤ 5 x the upper limit of the normal range (ULN)
Show all 12Show fewer
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN (participants with serum amylase > 5 x ULN remained eligible if serum lipase was ≤ 5 x ULN)
  • Adequate renal function
  • Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study period and for 12 weeks following the last dose of study drug.
  • Adult (≥ 18 years) males or non-pregnant females

Who cannot join

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Females who were breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Proven or suspected acute hepatitis in the 30 days prior to study entry
  • Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated to receive treatment for hepatitis C during the course of the study
  • Subjects experiencing decompensated cirrhosis
Show all 14Show fewer
  • Had an implanted defibrillator or pacemaker
  • Current alcohol or substance abuse
  • A 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 requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens
  • Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial.
  • Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids for immunosuppression during the study (eg, corticosteroids, immunoglobulins, and other immune-based or cytokine-based therapies)
  • Had any other clinical condition or prior therapy that, in the opinion of the Investigator, would have made the participant unsuitable for the study or unable to comply with the dosing requirements

Trial locations and contacts

151 sites in 14 countries.

151 sites in 14 countries

United States83 sites

  • Summa Health System Care Center

    Akron, Ohio, 44203

  • Upstate Infectious Disease Associates

    Albany, New York, 12208

  • CARE-ID

    Annandale, Virginia, 22003

  • Emory University

    Atlanta, Georgia, 30306

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Atlanta ID Group

    Atlanta, Georgia, 30309

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AHF Research Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Community Research Initiative of New England

    Boston, Massachusetts, 02111

  • Clinical and Translational Research Center - UNC Hospitals

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center

    Charlotte, North Carolina, 28207

  • Northwestern University

    Chicago, Illinois, 60611

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • Northstar Medical Center

    Chicago, Illinois, 60657

  • University of South Carolina

    Columbia, South Carolina, 29223

  • Trinity Health and Wellness Center

    Dallas, Texas, 75208

  • Southwest Infectious Disease Associates, Inc.

    Dallas, Texas, 75219

  • Infectious Disease Specialists of America

    Decatur, Georgia, 30033

  • Apex Research LLC

    Denver, Colorado, 80209

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • New York Hospital Queens

    Flushing, New York, 11355

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33311

  • Gary J. Richmond, M.D., P.A.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • The Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27834

  • Garcia Family Health Group

    Harlingen, Texas, 78550

  • Kaiser Permanente Medical Center

    Hayward, California, 94545

  • Clint Spencer Clinic

    Honolulu, Hawaii, 96813

  • Therapeutic Concepts, P.A.

    Houston, Texas, 77004

  • Gordon E. Crofoot MD PA

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Living Hope Education and Research Consultants

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente Medical Center

    Los Angeles, California, 90027

  • Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center

    Los Angeles, California, 90028

  • Lightsource Medical

    Los Angeles, California, 90036

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Oasis Clinic

    Los Angeles, California, 90059

  • Anthony Mills MD Inc

    Los Angeles, California, 90069

  • Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station

    Lutherville, Maryland, 21093

  • Mercer University School of Medicine

    Macon, Georgia, 31201

  • North Shore University Hospital--Division of Infectious Diseases

    Manhasset, New York, 11030

  • The Kinder Medical Group

    Miami, Florida, 33133

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Greiger Clinic

    Mount Vernon, New York, 10550

  • Beth Israel Medical Center

    New York, New York, 10003

  • Ricky K. Hsu, Md, Pc

    New York, New York, 10011

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • East Bay AIDS Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Valuhealthmd,Llc / Idocf

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94304

  • Infectious Disease Associates of NW FL

    Pensacola, Florida, 32504

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • University of California, Davis

    Sacramento, California, 95817

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • AHF Health Positive - Tampa Bay

    Safety Harbor, Florida, 34695

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Metropolis Medical/Dr.Fritz

    San Francisco, California, 94114

  • Kaiser Permanente Medical Center, San Francisco

    San Francisco, California, 94118

  • Southwest Care Center

    Sante Fe, New Mexico, 87505

  • Peter Shalit, M.D.

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Rockwood Pulmonary and Critical Care

    Spokane, Washington, 99204

  • Claudia T Martorell, MD., LLC dba The Research Institute

    Springfield, Massachusetts, 01105

  • Central West Clinical Research, Inc.

    St Louis, Missouri, 63108

  • Southampton Healthcare

    St Louis, Missouri, 63139

  • St. Joseph's Hospital d/b/a Comprehensive Research Institute

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Dupont Circle Physician's Group

    Washington D.C., District of Columbia, 20009

  • Whitman-Walker Clinic

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, PC

    Washington D.C., District of Columbia, 20036

  • Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

France10 sites

  • Hopital Raymond Poincare

    Garches, 92380

  • Hôpital de la Croix-Rousse

    Lyon, 69288

  • Chu Hotel Dieu

    Nantes, 44093

  • CHU Nice - Archet 1

    Nice, 06200

  • Hopital Bichat Claude Bernard

    Paris, 75018

  • HOSPITAL SAINT LOUIS - Services des Maladies Infectieuses

    Paris, 75475

  • Hopital Saint Antoine- Service Maladies infectieuses

    Paris, 75571

  • Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses

    Paris, 75651

  • Hopital Tenon Service des Maladies infectieuses et tropicales

    Paris, 75970

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208

Other trials in France

Australia8 sites

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales, 02010

  • St Vincent's Hospital, Sydney

    Darlinghurst, 02010

  • Taylor Square Private Clinic

    Darlinghurst, 02010

  • Northside Clinic

    Fitzroy North, 03068

  • Clinical Research - Infectious Diseases Unit Alfred Hospital

    Melbourne, 03004

  • Prahran Market Clinic

    Prahran, 03181

  • Albion Street Centre

    Surry Hills, 02010

  • East Sydney Doctors

    Sydney, 02010

Other trials in Australia

Canada8 sites

  • Clinique médicale L' Actuel

    Montreal, Quebec, H2L 4P9

  • McGill University Health Center, Montreal Chest Institute

    Montreal, Quebec, H2X 2P4

  • The Ottawa Hospital, General Campus

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Maple Leaf Research Maple Leaf Medical Clinic

    Toronto, Ontario, M5G 1K2

  • University Health Network/Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Division of HIV/AIDS, St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Vancouver ID Research and Care Centre Society

    Vancouver, British Columbia, V6Z2C7

Other trials in Canada

Germany8 sites

  • EPIMED GmbH

    Berlin, 12157

  • Medizinische Universitätsklinik I der Friedrich-Wilhelms Universität Bonn

    Bonn, 53105

  • Department of Dermatology University Hospital Essen

    Essen, 45122

  • Private Practice Gute & Locher & Lutz, Infektiologikum

    Frankfurt am Main, 60311

  • Division of Infectious Disease, Department of Medicine, University Hospital Freiburg

    Freiburg im Breisgau, 79106

  • ICH Study Center

    Hamburg, 20146

  • Universitätsklinikum Eppendorf Ambulanzzentrum des UKE GmbH, Infekiologie

    Hamburg, 20246

  • MUC Research GmbH

    München, 80335

Other trials in Germany

United Kingdom7 sites

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Ridu, Wgh

    Edinburgh, EH42XU

  • Clinical Research, Grahame Hayton Unit Ambrose King Centre, The Royal London Hospital

    London, E11 BB

  • Royal Free NHS Trust,

    London, NW32QG

  • Guys and St Thomas' NHS trust

    London, SE7 4EH

  • Chelsea and Westminster Hospital

    London, Sw10 9NH

  • North Manchester General Hospital

    Manchester, M8 5RB

Other trials in United Kingdom

Italy6 sites

  • Ospedali Riuniti

    Bergamo, 24128

  • IRCCS Ospedale San Raffaele Centro San Luigi, Unità Operativa di Malattie Infettive

    Milan, 20127

  • I Div Infectious Diseases, Luigi Sacco Hospital

    Milan, 20157

  • San Gerardo Hospital - Uo Malattie Infettive

    Monza, 20092

  • Foundation "IRCCS Policlinico San Matteo Hospital"

    Pavia, 27100

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

    Rome, 00149

Other trials in Italy

Spain6 sites

  • Hospital General Universitario Alicante

    Alicante, 03010

  • Hospital Universitari de Bellvitge

    Cataluña, 08907

  • Hospital Universitario de Elche, Unidad de Enfermedades Infecciosas

    Elche, 03202

  • Hospital Universitario 12 Octubre

    Madrid, 28041

  • Unidad HIV. Hospital 12 de Octubre

    Madrid, 28041

  • Hospital La Paz

    Madrid, 28046

Other trials in Spain

Austria3 sites

  • LKH Medical University Graz West, Department of Internal Medicine

    Graz, A-8020

  • Universitätsklinikum Innsbruck Universitätsklinik für Dermatologie und Venerologie

    Innsbruck, A6020

  • Department of Dermatology, Allergy, and Infectious Disease University Vienna Medical School

    Vienna, 01090

Other trials in Austria

Belgium3 sites

  • Institute of Tropical Medicine

    Antwerp, 2000

  • Cliniques Universitaires Saint-Luc - UCL

    Brussels, 01200

  • University Hospitals Leuven

    Leuven, 03000

Other trials in Belgium

Portugal3 sites

  • Hospital de Santa Maria - CHLN, EPE

    Lisbon, 1649-035

  • Serviço de Doenças Infecciosas, Hospital S. Joao

    Porto, 4200-319

  • Hospital de Joaquim urbano

    Porto, 4369-004

Other trials in Portugal

Switzerland3 sites

  • Universitätsklinik für Infektiologie

    Bern, 03010

  • CHUV

    Lausanne, 01011

  • University Hospital Zurich

    Zurich, 08091

Other trials in Switzerland

Netherlands2 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC

  • Erasmus MC

    Rotterdam, PB 2040

Other trials in Netherlands

Puerto Rico1 site

  • Clinical Research Puerto Rico

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications.

Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

Conditions
HIV-1 Infection
Being tested
FTC/RPV/TDF, EFV/FTC/TDF
Keywords
HIV, HIV-1, Antiretroviral Treatment-Naïve

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 (TDF) 300 mg single-tablet regimen administered orally once daily with a meal

  • EFV/FTC/TDFDrug

    Also called Atripla®

    Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg single-tablet regimen administered orally once daily on an empty stomach, preferably at bedtime

Study groups in NCT01309243
Study groupRoleWhat they receive
FTC/RPV/TDFExperimentalNot described
Receives: Drug: FTC/RPV/TDF
EFV/FTC/TDFExperimentalNot described
Receives: Drug: EFV/FTC/TDF

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 48

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

    The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

    Measured: Week 48

Secondary outcomes (9)

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.

    Measured: Baseline to Week 96

  2. Change From Baseline in CD4 Cell Count at Week 48

    Measured: Baseline to Week 48

  3. Change From Baseline in CD4 Cell Count at Week 96

    Measured: Baseline to Week 96

  4. Change From Baseline in Fasting Total Cholesterol at Week 48

    Measured: Baseline to Week 48

  5. Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48

    Measured: Baseline to Week 48

  6. Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48

    Measured: Baseline to Week 48

  7. Change From Baseline in Fasting Triglycerides at Week 48

    Measured: Baseline to Week 48

  8. Development of HIV-1 Drug Resistance Through Week 96, All Participants

    Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.

    Measured: Baseline to Week 96

  9. Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance

    Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.

    Measured: Baseline to Week 96

Timeline

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

  1. First posted7 Mar 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionSep 2012
  4. Study completionFeb 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
799 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309243
Sponsor's protocol ID
GS-US-264-0110
Status last verified
Feb 2015
First submitted
3 Mar 2011
Last updated
25 Feb 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FTC/RPV/TDF and EFV/FTC/TDF in people with HIV-1 Infection, run by Gilead Sciences at 151 sites in 14 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 12 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 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, France, Australia, Canada, Germany and 9 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 27 Nov 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 48 (time frame: Week 48). 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 NCT01309243.

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 25 Feb 2015.

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