Acquired Immunodeficiency SyndromePhase 3NCT01440569
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
A Phase 3 study testing COBI, DRV and NRTIs in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 49 sites in 2 countries.
Trial summary
This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV Infections
- What is being tested?
- COBI, DRV and NRTIs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 49 sitesin 2 countries
- Study dates
- Sep 2011to Oct 2015
- 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
- Adult ≥ 18 years males or non-pregnant females
- Ability to understand and sign a written informed consent form
- General medical condition that does not interfere with the assessments and the completion of the trial
- Treatment Naive: No prior use of any approved or investigational antiretroviral drug for any length of time OR
- Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening
- Plasma HIV-1 RNA levels ≥ 1000 copies/mL at Screening
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- Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase inhibitors (NRTIs) and no darunavir resistance-associated mutations
- Normal electrocardiogram (ECG)
- Hepatic transaminases ≤ 2.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL
- Adequate hematologic function
- Serum amylase ≤ 2 × ULN and serum lipase ≤ 3 × ULN
- Adequate renal function: Estimated glomerular filtration rate ≥ 80 mL/min
- Females of childbearing potential must agree to utilize protocol-recommended methods of contraception, or be 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.
- Male subjects must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse from the Screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or be nonheterosexually active, practice sexual abstinence, or be vasectomized.
Who cannot join
- Previous or current use of darunavir
- A new AIDS-defining condition diagnosed within the 30 days prior to Screening
- Females who are breastfeeding
- Positive serum pregnancy test (if female of childbearing potential)
- Proven or suspected acute hepatitis in the 30 days prior to study entry
- Subjects receiving drug treatment for hepatitis C virus (HCV), or subjects who are anticipated to receive treatment for HCV during the course of the study
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- Have a history of ongoing active liver disease or experiencing decompensated cirrhosis irrespective of liver enzyme levels
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use that may interfere with subject study compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma
- Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
- Participation in any other clinical trial
- Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements.
- Subjects receiving ongoing therapy with any of the medications, including drugs not to be used with cobicistat, darunavir, or investigator selected NRTIs; or subjects with any known allergies to cobicistat tablets, darunavir tablets or contraindications for the 2 NRTIs as part of the regimen.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States48 sites
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, 22003
Atlanta ID group
Atlanta, Georgia, 30309
Central Texas Clinical Research
Austin, Texas, 78705
Be Well Medical Center
Berkley, Michigan, 48072
Community Research Initiative of New England
Boston, Massachusetts, 02215
Carolinas Medical Center-Myer's Park Infectious Disease Clinic
Charlotte, North Carolina, 28079
Howard Brown Health Center
Chicago, Illinois, 60613
Northstar Medical Center
Chicago, Illinois, 60657
Trinity Health and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, 75208
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, 75219
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
Apex Research LLC
Denver, Colorado, 80220
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Gary J. Richmond,M.D., P.A.
Fort Lauderdale, Florida, 33316
Tarrant County Infectious Disease
Fort Worth, Texas, 76104
Midway Immunology and Research Center
Ft. Pierce, Florida, 34983
Hawaii Center for AIDS, University of Hawaii
Honolulu, Hawaii, 96816
Therapeutic Concepts, PA
Houston, Texas, 77004
Gordon Crofoot MD, PA
Houston, Texas, 77098
Long Beach Education and Research Consultants, PC
Long Beach, California, 90813
DCOL Center for Clinical Research
Longview, Texas, 75605
Peter J Ruane MD Inc.
Los Angeles, California, 90036
Anthony Mills MD Inc
Los Angeles, California, 90069
Johns Hopkins University
Lutherville, Maryland, 21093
Mercer University
Macon, Georgia, 31220
North Shore University Hospital / Division of Infectious Diseases
Manhasset, New York, 11030
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, 33139
HIV Program Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Greiger Clinic
Mount Vernon, New York, 10550
Beth Israel Medical Center
New York, New York, 10003
Saint Michael's Medical Center
Newark, New Jersey, 07102
Orlando Immunology Center
Orlando, Florida, 32803
Stanford University
Palo Alto, California, 94304
University of PA
Philadelphia, Pennsylvania, 19104
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Spectrum Medical Group
Phoenix, Arizona, 85012
Miriam Hospital
Providence, Rhode Island, 02906
Kaiser Permanente Medical Group
Sacramento, California, 95825
Central West Clinical Research Inc
Saint Louis, Michigan, 63108
La Playa Medical Group and Clinical Research
San Diego, California, 92103
Metropolis Medical
San Francisco, California, 94109
Swedish Medical Center
Seattle, Washington, 89104
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
St. Joseph's Comprehensive Research Institute
Tampa, Florida, 33614
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009
Whitman-Walker Health
Washington D.C., District of Columbia, 20009
Wake Forest University Health Services
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV-1 Infected, Antiretroviral Treatment-Naïve and -Experienced Adults With No Darunavir Resistance-associated Mutations
This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations.
After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Being tested
- COBI, DRV, NRTIs
- Keywords
- HIV-1, HIV, Treatment Naïve, Treatment Experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
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
150 mg tablet administered orally with food once daily
DRVDrug
Also called Prezista®, TMC114
800 mg (2 x 400 mg tablets) administered orally with food once daily
NRTIsDrug
Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.
| Study group | Role | What they receive |
|---|---|---|
| COBI-boosted DRV | Experimental | Participants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase. Receives: Drug: COBI; Drug: DRV; Drug: NRTIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24
Measured: Up to 24 weeks
Secondary outcomes (6)
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)
Measured: Week 24
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)
Measured: Week 48
Change From Baseline in CD4+ Cell Count at Week 24
Measured: Baseline; Week 24
Change From Baseline in CD4+ Cell Count at Week 48
Measured: Baseline; Week 48
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24
Measured: Up to 24 weeks
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2012
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Marshall Fordyce, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440569
- Sponsor's protocol ID
- GS-US-216-0130
- Other IDs
- 2011-003501-22
- Status last verified
- Oct 2016
- First submitted
- 22 Sep 2011
- Last updated
- 14 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV-1 Infected, Antiretroviral Treatment-Naïve and -Experienced Adults With No Darunavir Resistance-associated Mutations
- ClinicalTrials.gov ID
- NCT01440569
- Acronym / sponsor ID
- GS-US-216-0130
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Keywords
- HIV-1, HIV, Treatment Naïve, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Posted 28 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations.
After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COBI-boosted DRV | Experimental | Drug: COBI, Drug: DRV, Drug: NRTIsParticipants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult ≥ 18 years males or non-pregnant females
- Ability to understand and sign a written informed consent form
- General medical condition that does not interfere with the assessments and the completion of the trial
- Treatment Naive: No prior use of any approved or investigational antiretroviral drug for any length of time OR
- Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening
Key exclusion criteria (14 listed)
- Previous or current use of darunavir
- A new AIDS-defining condition diagnosed within the 30 days prior to Screening
- Females who are breastfeeding
- Positive serum pregnancy test (if female of childbearing potential)
- Proven or suspected acute hepatitis in the 30 days prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COBIAlso: Tybost®, GS-9350150 mg tablet administered orally with food once daily | Drug | COBI-boosted DRV |
| DRVAlso: Prezista®, TMC114800 mg (2 x 400 mg tablets) administered orally with food once daily | Drug | COBI-boosted DRV |
| NRTIsParticipants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC. | Drug | COBI-boosted DRV |
Primary outcome
Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24
Time frame: Up to 24 weeks
6 secondary outcomes
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)
Time frame: Week 24
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)
Time frame: Week 48
Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline; Week 24
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24
Time frame: Up to 24 weeks
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48
Time frame: Up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marshall Fordyce, MD study director
Gilead Sciences
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COBI, DRV and NRTIs in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 49 sites in 2 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 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Puerto Rico. 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 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 Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24 (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2016.