Overview

This trial is active, not recruiting.

Conditions acquired immunodeficiency syndrome, hiv infections
Treatments cobicistat, darunavir, nrti
Phase phase 3
Sponsor Gilead Sciences
Start date October 2011
End date August 2012
Trial size 300 participants
Trial identifier NCT01440569, 2011-003501-22, GS-US-216-0130

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
cobicistat COBI, GS-9350
cobicistat 150 mg tablet with food daily for 48 weeks
darunavir DRV, Prezista®
darunavir 800 mg (2 x 400 mg tablets) with food daily for 48 weeks
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.

Primary Outcomes

Measure
Onset of treatment emergent Grade 3 or Grade 4 adverse events
time frame: Baseline to Week 24

Secondary Outcomes

Measure
Proportion of participants achieving HIV RNA < 50 copies/mL at Weeks 24 and 48
time frame: Week 24 and 48
The change from baseline in CD4+ cell count at Weeks 24 and 48
time frame: Up to 48 weeks
Incidence of treatment emergent adverse events through 24 and 48 weeks that lead to discontinuation of study drug
time frame: Up to 48 weeks
Proportion of participants experiencing any treatment emergent adverse event through 24 and 48 weeks
time frame: Up to 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.