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

September 22, 2011
May 28, 2014
October 2011
August 2012   (final data collection date for primary outcome measure)
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.
The primary safety endpoint is the onset of any treatment emergent Grade 3 or Grade 4 adverse events [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Onset of any treatment emergent Grade 3 or Grade 4 adverse event through 24 weeks.
Complete list of historical versions of study NCT01440569 on ClinicalTrials.gov Archive Site
  • 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.
  • The proportion of subjects achieving HIV 1 RNA < 50 copies/mL [ Time Frame: 24 & 48 Weeks ] [ Designated as safety issue: No ]
    The proportion of subjects achieving HIV 1 RNA < 50 copies/mL at Weeks 24 and 48.
  • The change from baseline in CD4+ cell count [ Time Frame: 24 & 48 Weeks ] [ Designated as safety issue: No ]
    The change from baseline in CD4+ cell count at Weeks 24 and 48.
Not Provided
Not Provided
 
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • 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.
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
Interventions:
  • Drug: Cobicistat
  • Drug: Darunavir
  • Drug: NRTI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
January 2015
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01440569
GS-US-216-0130, 2011-003501-22
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Marshall Fordyce, MD Gilead Sciences
Gilead Sciences
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP