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HIVPhase 3NCT01106586

Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

A Phase 3 study testing Stribild, ATV and Ritonavir in people with HIV and HIV Infections, run by Gilead Sciences at 146 sites in 17 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

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, HIV Infections
What is being tested?
Stribild, ATV and Ritonavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
708 participants
Where
146 sitesin 17 countries
Study dates
Apr 2010to Sep 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, which must be obtained prior to initiation of study procedures
  • Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time
  • Screening genotype report must show sensitivity to FTC, TDF, and ATV
  • Normal electrocardiogram (ECG)
  • Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula)
Show all 13Show fewer
  • Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x the upper limit of the normal range (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Males and Females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Who cannot join

  • A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
  • Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Implanted defibrillator or pacemaker
Show all 12Show fewer
  • 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
  • Medications contraindicated for use with EVG, COBI, FTC, TDF, ATV, or ritonavir or subjects with any known allergies to the excipients of Stribild tablets, Truvada tablets, ATV capsules or ritonavir tablets
  • Participation in any other clinical trial without prior approval
  • 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 the dosing requirements

Trial locations and contacts

146 sites in 17 countries.

146 sites in 17 countries

United States86 sites

  • Summa Health System

    Akron, Ohio, 44304

  • Upstate ID Association

    Albany, New York, 12208

  • Albany Medical College

    Albany, New York, 12209

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

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Infectious Disease Solutions, PC

    Atlanta, Georgia, 30309

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AHF Research Center

    Beverly Hills, California, 90211

  • STAR Health Care Center (SUNY Downstate)

    Brooklyn, New York, 11203

  • Carolinas Medical Center-Myers Park

    Charlotte, North Carolina, 28207

  • Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of South Carolina

    Columbia, South Carolina, 29203

  • CSI Clinical Trials, Inc.

    Costa Mesa, California, 92626

  • Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)

    Dallas, Texas, 75204

  • Trinity Health and Wellness Center/AIDS Arms, Inc.

    Dallas, Texas, 75208

  • Apex Research, LLC

    Denver, California, 80209

  • National Jewish Health

    Denver, Colorado, 80206

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Broward Health/Comprehensive Care 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

  • East Carolina University

    Greenville, North Carolina, 27834

  • Garcia's Family Health Group

    Harlingen, Texas, 78550

  • Kaiser Permanente Hospital

    Hayward, California, 94545

  • ID Care

    Hillsborough, New Jersey, 08844

  • Leahi Hospital

    Honolulu, Hawaii, 96816

  • Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)

    Houston, Texas, 77004

  • Gordon E. Crofoot MD PA

    Houston, Texas, 77098

  • Research Access Network

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Health for Life Clinic PLLC

    Little Rock, Arkansas, 72207

  • Living Hope Clinical Foundation

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente

    Los Angeles, California, 90027

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

    Los Angeles, California, 90028

  • Peter J Ruane, MD, Inc

    Los Angeles, California, 90036

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Anthony Mills MD Inc

    Los Angeles, California, 90069

  • Mercer University School of Medicine

    Macon, Georgia, 31210

  • North Shore University Hospital

    Manhasset, New York, 11030

  • The Kinder Medical Group

    Miami, Florida, 33133

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Greiger Clinic

    Mount Vernon, New York, 10550

  • Yale University HIV Clinical Trials Program

    New Haven, Connecticut, 06033

  • Beth Israel Medical Center

    New York, New York, 10003

  • Chelsea Village Medical, PC

    New York, New York, 10011

  • Saint Michaels 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

  • IDOCF/ ValueHealthMD, LLC

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94303

  • Division of Infectious Diseases, Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • AIDS Care

    Rochester, New York, 14604

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Metropolitan Medical

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center, Clinical Trials Unit

    San Francisco, California, 94118

  • Peter Shalit, M.D.

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • The Research Institute

    Springfield, Massachusetts, 01107

  • Baystate Infectious Diseases Clinical Research

    Springfield, Massachusetts, 01199

  • CentralWest Clinical Research

    St Louis, Missouri, 63108

  • Division of Infectious Diseases, St. Louis University Medical Center

    St Louis, Missouri, 63110

  • Southampton Healthcare

    St Louis, Missouri, 63139

  • The Stamford Hospital

    Stamford, Connecticut, 06902

  • University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

    Tampa, Florida, 33602

  • Infectious Disease Research Institute Inc.

    Tampa, Florida, 33614

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33615

  • Montiefiore Medical Center- AIDS Center

    The Bronx, New York, 10467

  • Treasure Coast Infectious Disease Consultants

    Vero Beach, Florida, 32960

  • Garden State Infectious Diseases Associates, PA

    Voorhees Township, New Jersey, 08043

  • Dupont Circle Physicians 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

  • George Washington University 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

France11 sites

  • Service des Maladies Infectieuses, CHU de Caen

    Caen, 14033

  • Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales

    Lyon, 69317

  • CHU Gui de Chauliac, Maladies Infectieuses Dpt

    Montpellier, 34295

  • CHU de Nantes Hopital de l'Hotel Dieu

    Nantes, 44093

  • Centre Hospitalier Universitaire de Nice

    Nice, 06200

  • Department of Infectious Diseases, Saint-Louis hospital

    Paris, 75010

  • Hopital Saint Antoine, Service De Maladies Infectieuses

    Paris, 75012

  • Bichat Hospital

    Paris, 75018

  • Tenon Hospital, UPMC

    Paris, 75020

  • Hopital Pitie-Salpetriere

    Paris, 75651

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208

Other trials in France

Australia8 sites

  • Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)

    Carlton, Victoria, 3053

  • Holdsworth House Medical practice

    Darlinghurst, New South Wales, 2010

  • National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales

    Darlinghurst, New South Wales, 2010

  • Taylor Square Private Clinica

    Darlinghurst, N.S.W. 2011

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Northside Clinic

    Melbourne, Victoria, 3068

  • Albion Street Centre

    Sydney, New South Wales, 2010

  • East Sydney Doctors

    Sydney, New South Wales, 2010

Other trials in Australia

Germany8 sites

  • 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, 40237

  • Infektio Research GmbH / Infektiologikum Frankfurt

    Frankfurt am Main, 60311

  • Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68

    Frankfurt am Main, 60590

  • ICH Study Center Hamburg

    Hamburg, 20146

  • University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

    Hamburg, 20246

  • MUC Research GmbH

    München, 80335

Other trials in Germany

Canada7 sites

  • Southern Alberta Clinic

    Calgary, Alberta, T2R0X7

  • Clinique medicale l'Actuel

    Montreal, Quebec, H2L 4P9

  • Clinique Medicale du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

    Toronto, Ontario, M5B1L6

  • University Health Network, Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

United Kingdom6 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, East Sussex, BN2 1ES

  • Barts and the London NHS Trust

    London, E1 1BB

  • Homerton University Hospital

    London, E9 6SR

  • Chelsea and Westminster Hospital Foundation Trust

    London, SW10 9NH

  • St. Mary's Hospital, London (Imperial College, London)

    London, W2 1NY

  • North Manchester General Hospital

    Manchester, Lancashire, M8 5RB

Other trials in United Kingdom

Austria3 sites

  • LKH Graz West

    Graz, A-8010

  • Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna

    Vienna, 1090

  • Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital

    Vienna, 1140

Other trials in Austria

Belgium3 sites

  • CHU Saint-Pierre University Hospital

    Brussels, 1000

  • Hôpital Universitaire Erasme - ULB

    Brussels, 1070

  • University of Ghent

    Ghent, 9000

Other trials in Belgium

Italy3 sites

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20127

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

    Rome, 00149

  • Dipartimento di Malattie Infettive

    Torino, 10149

Other trials in Italy

Netherlands2 sites

  • Onze lieve vrouw gasthuis

    Amsterdam

  • Erasmus MC, Internal Medicine, Section of Infectious Diseases

    Rotterdam, 3000 CA

Other trials in Netherlands

Puerto Rico2 sites

  • Clinical Research Puerto Rico

    San Juan, 00909

  • VA Caribbean Healthcare System

    San Juan, 00921

Other trials in Puerto Rico

Thailand2 sites

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

Other trials in Thailand

Denmark1 site

  • Epidemiklinikken 5112, Rigshospitalet

    Copenhagen, 2000

Other trials in Denmark

Mexico1 site

  • Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

Other trials in Mexico

Portugal1 site

  • Serviço de Doenças Infecciosas, Hospital de São João

    Porto, 4202-451

Other trials in Portugal

Sweden1 site

  • Venhälsan, Södersjukhuset

    Stockholm, 11883

Other trials in Sweden

Switzerland1 site

  • CHUV

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

Conditions
HIV, HIV Infections
Being tested
Stribild, ATV, Ritonavir, FTC/TDF, Stribild Placebo
Keywords
HIV 1 Infection, Treatment Naive
Medical subject headings
HIV Infections

What participants receive

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

  • StribildDrug

    Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily

  • ATVDrug

    Atazanavir 300 mg capsule administered orally once daily

  • RitonavirDrug

    Also called Norvir®

    Ritonavir (RTV; /r) 100 mg tablet administered orally once daily

  • FTC/TDFDrug

    Also called Truvada

    FTC/TDF 200/300 mg tablet administered orally once daily

  • Stribild PlaceboDrug

    Placebo to match Stribild administered orally once daily

  • ATV PlaceboDrug

    Placebo to match ATV administered orally once daily

  • RTV PlaceboDrug

    Placebo to match RTV administered orally once daily

  • FTC/TDF PlaceboDrug

    Placebo to match FTC/TDF administered orally once daily

Study groups in NCT01106586
Study groupRoleWhat they receive
StribildExperimentalNot described
Receives: Drug: Stribild; Drug: ATV Placebo; Drug: RTV Placebo; Drug: FTC/TDF Placebo
ATV/r + FTC/TDFActive comparatorNot described
Receives: Drug: ATV; Drug: Ritonavir; Drug: FTC/TDF; Drug: Stribild Placebo

What is being measured

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

  1. The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48

    Measured: Week 48

Secondary outcomes (6)

  1. The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96

    Measured: Week 96

  2. The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144

    Measured: Week 144

  3. The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192

    Measured: Week 192

  4. The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm

    Measured: Week 48

  5. The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192

    Change = value of the relevant time point minus the baseline value

    Measured: Baseline; Weeks 48, 96, 144, and 192

  6. The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

    Measured: 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 posted20 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionSep 2011
  4. Study completionSep 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106586
Sponsor's protocol ID
GS-US-236-0103
Status last verified
Oct 2015
First submitted
14 Apr 2010
Last updated
11 Nov 2015
Data monitoring committee
Yes

Publications

  • DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.

    PubMed 22748590

  • Rockstroh JK, DeJesus E, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Plummer A, Abram M, Cheng AK, Fordyce MW, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):483-6. doi: 10.1097/QAI.0b013e318286415c.

    PubMed 23337366

  • Clumeck N, Molina JM, Henry K, Gathe J, Rockstroh JK, DeJesus E, Wei X, White K, Fordyce MW, Rhee MS, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):e121-4. doi: 10.1097/QAI.0000000000000089. No abstract available.

    PubMed 24346640

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stribild, ATV and Ritonavir in people with HIV and HIV Infections, run by Gilead Sciences at 146 sites in 17 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 13 inclusion and 12 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 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, France, Australia, Germany, Canada and 12 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 22 Oct 2012). 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?

The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (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 NCT01106586, which also lists 3 linked publications.

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 11 Nov 2015.

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