Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01440569
First received: September 22, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections
Drug: Cobicistat
Drug: Darunavir
Drug: NRTI
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Onset of treatment emergent Grade 3 or Grade 4 adverse events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    The onset of any treatment emergent Grade 3 or Grade 4 adverse event through 24 weeks will be summarized.


Secondary Outcome Measures:
  • Proportion of participants achieving HIV RNA < 50 copies/mL at Weeks 24 and 48 [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
  • The change from baseline in CD4+ cell count at Weeks 24 and 48 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events through 24 and 48 weeks that lead to discontinuation of study drug [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants experiencing any treatment emergent adverse event through 24 and 48 weeks [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    The proportion of participants experiencing any adverse event through Week 24 and Week 48 will be summarized.


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: January 2015
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cobicistat boosted darunavir
Darunavir 800 mg (2 x 400 mg tablets) with food daily + cobicistat 150 mg tablet with food daily + two (2) Investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs) selected by resistance testing at screening, administered orally
Drug: Cobicistat
cobicistat 150 mg tablet with food daily for 48 weeks
Other Name: COBI, GS-9350
Drug: Darunavir
darunavir 800 mg (2 x 400 mg tablets) with food daily for 48 weeks
Other Name: DRV, Prezista®
Drug: NRTI
Participants will receive 2 investigator-selected nucleoside analogue reverse transcriptase inhibitors (NRTIs), which may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC, administered according to prescribing information.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Naïve: 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 ≥ 500 copies/mL at screening
  • 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 non heterosexually 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 non-heterosexually active, practice sexual abstinence, or be vasectomized.

Exclusion Criteria:

  • 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, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440569

  Show 50 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Marshall Fordyce, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01440569     History of Changes
Other Study ID Numbers: GS-US-216-0130, 2011-003501-22
Study First Received: September 22, 2011
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV-1
HIV
Treatment Naïve
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Darunavir
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 30, 2014