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

Not Recruiting

Trial ID: NCT01440569


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.

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

Stanford Investigator(s)

Philip Grant
Philip Grant

Assistant Professor of Medicine (Infectious Diseases)


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 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

   - Plasma HIV-1 RNA levels ≥ 1000 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 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

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 virus (HCV), or subjects who are
   anticipated to receive treatment for HCV 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.


drug: COBI

drug: DRV

drug: NRTIs

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz