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HIV-1 InfectionPhase 2NCT00892437

Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

A Phase 2 study testing COBI, RTV and ATV in people with HIV-1 Infection, run by Gilead Sciences at 31 sites in United States.

Completed

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

Official record
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Trial summary

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. 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?
COBI, RTV and ATV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
31 sitesUnited States
Study dates
May 2009to Jan 2015
Phase
Phase 2
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 ≥ 5,000 copies/mL
  • No prior use of any approved or experimental anti-HIV drug
  • Normal ECG (or if abnormal, determined by the investigator to be not clinically significant)
  • Adequate renal function (estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula)
  • Hepatic transaminases ≤ 2.5 × upper limit of normal
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  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
  • Cluster of differentiation 4 (CD4) cell count > 50 cells/µL
  • Serum amylase ≤ 1.5 × ULN (subjects with serum amylase >1.5 × ULN remained eligible if serum lipase is ≤ 1.5 × ULN)
  • Normal thyroid-stimulating hormone
  • Negative serum pregnancy test (females of childbearing potential only)
  • 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 drugs
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Who cannot join

  • New AIDS-defining condition diagnosed within the 30 days prior to screening
  • Documented drug resistance to nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), or primary PI resistance mutation(s)
  • Hepatitis B surface antigen positive
  • Hepatitis C antibody positive
  • Participants experiencing cirrhosis
  • Participants experiencing ascites
Show all 24Show fewer
  • Participants experiencing encephalopathy
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Vaccinated within 90 days of study dosing
  • History or family history of Long QT Syndrome or have a family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30 years
  • Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
  • Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) interval at screening (eg, a prolongation of the QTcF interval of greater than 450 msec for males and greater than 470 msec for females)
  • PR interval greater than or equal to 200 msec or less than or equal to 120 msec on ECG at screening
  • QRS greater than or equal to 120 msec on ECG at screening
  • Implanted defibrillator or pacemaker
  • Subjects receiving ongoing therapy with any disallowed medications
  • Current alcohol or substance use judged to potentially interfere with subject study compliance
  • History of or ongoing malignancy (including untreated carcinoma in-situ) 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
  • Participation in any other clinical trial without prior approval
  • Medications contraindicated for use with ATV, RTV, FTC, or TDF
  • Any known allergies to the excipients of ATV capsules, RTV capsules, COBI tablets or FTC/TDF tablets
  • Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Chase Brexton Health Services, Inc.

    Baltimore, Maryland, 21201

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AIDS Healthcare Foundation-Research Center

    Beverly Hills, California, 90804

  • Northstar Medical Center

    Chicago, Illinois, 60657

  • Nicholaos Bellos, MD, PA

    Dallas, Texas, 75204

  • AIDS Arms/ Peabody Health Center

    Dallas, Texas, 75215

  • Infectious Disease Specialists of Atlanta (IDSA)

    Decatur, Georgia, 30033

  • Denver Infectious Disease Consultants, PLLC

    Denver, Colorado, 80220

  • Gary Richmond, MD, PA, Inc.

    Fort Lauderdale, Florida, 33316

  • Gordon E. Crofoot, MD, PA

    Houston, Texas, 77098

  • Therapeutic Concepts, P.A.

    Houston, Texas, 77478

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Health for Life Clinic, PLLC

    Little Rock, Arkansas, 72207

  • The Living Hope Foundation

    Long Beach, California, 90813

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • ValuehealthMD, LLC

    Orlando, Florida, 32806

  • Southwest Center for HIV/AIDS

    Phoenix, Arizona, 85006

  • David J. Shamblaw, MD Inc.

    San Diego, California, 92103

  • Metropolis Medical

    San Francisco, California, 94115

  • Southwest C.A.R.E. Center

    Santa Fe, New Mexico, 87505

  • TribalMed

    Seattle, Washington, 98103

  • Central West Healthcare

    St Louis, Missouri, 63108

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33614

  • 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

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir (ATV/GS-9350) Compared to Ritonavir-boosted Atazanavir (ATV/r) in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.

Conditions
HIV-1 Infection
Being tested
COBI, RTV, ATV, FTC/TDF, COBI placebo
Keywords
HIV, HIV-1, Antiretroviral Treatment-Naive

What participants receive

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

  • COBIDrug

    Also called Tybost®, GS-9350

    Cobicistat (COBI) 150 mg tablet administered orally once daily

  • RTVDrug

    Also called Norvir®

    Ritonavir (RTV) 100 mg soft gelatin capsule administered orally once daily

  • ATVDrug

    Also called Reyataz®

    Atazanavir (ATV) 300 mg capsule administered orally once daily

  • FTC/TDFDrug

    Also called Truvada®

    Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily

  • COBI placeboDrug

    Placebo to match COBI administered orally once daily

  • RTV placeboDrug

    Placebo to match RTV administered orally once daily

Study groups in NCT00892437
Study groupRoleWhat they receive
ATV+COBI+FTC/TDFExperimentalCOBI + RTV placebo +ATV+FTC/TDF for 48 weeks
Receives: Drug: COBI; Drug: ATV; Drug: FTC/TDF; Drug: RTV placebo
ATV+RTV+FTC/TDFActive comparatorRTV + COBI placebo +ATV+FTC/TDF for 48 weeks
Receives: Drug: RTV; Drug: ATV; Drug: FTC/TDF; Drug: COBI placebo

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

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.

    Measured: Week 24

Secondary outcomes (5)

  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 missing = failure method.

    Measured: Week 48

  2. Change From Baseline in HIV-1 RNA at Week 24

    The change from baseline in log_10 HIV-1 RNA at Week 24 was analyzed.

    Measured: Baseline to Week 24

  3. Change From Baseline in HIV-1 RNA at Week 48

    The change from baseline in log_10 HIV-1 RNA at Week 48 was analyzed.

    Measured: Baseline to Week 48

  4. Change From Baseline in CD4 Cell Count at Week 24

    The change from baseline in CD4 cell count at Week 24 was analyzed.

    Measured: Baseline to Week 24

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

    The change from baseline in CD4 cell count at Week 48 was analyzed.

    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 posted4 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2009
  4. Study completionJan 2015

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00892437
Sponsor's protocol ID
GS-US-216-0105
Status last verified
Jan 2016
First submitted
30 Apr 2009
Last updated
15 Feb 2016
Data monitoring committee
Yes

Publications

  • Elion R, Cohen C, Gathe J, Shalit P, Hawkins T, Liu HC, Mathias AA, Chuck SL, Kearney BP, Warren DR; GS-US-216-0105 Study Team. Phase 2 study of cobicistat versus ritonavir each with once-daily atazanavir and fixed-dose emtricitabine/tenofovir df in the initial treatment of HIV infection. AIDS. 2011 Sep 24;25(15):1881-6. doi: 10.1097/QAD.0b013e32834b4d48.

    PubMed 21811136

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing COBI, RTV and ATV in people with HIV-1 Infection, run by Gilead Sciences at 31 sites in United States.

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 24 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Oct 2014). 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 (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 NCT00892437, which also lists 1 linked publication.

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 15 Feb 2016.

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