Status:
COMPLETED
Elvitegravir/Cobicistat/Tenofovir DF/Emtricitabine With Darunavir Treatment Simplification Strategy
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV Infection
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The study aims to assess the safety and efficacy of darunavir 800mg plus the co-formulated elvitegravir/cobicistat/tenofovir disoproxil fumarate (DF)/emtricitabine (Stribild) tablet as a simplificatio...
Detailed Description
Eligible, consenting subjects will be assessed at baseline and weeks 2, 12, 24, 36, and 48. Study medications will be dispensed at all visits except week 2, and all participants will commence taking o...
Eligibility Criteria
Inclusion
- HIV positive adults \> or = 19 years of age
- receiving stable therapy including one or two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in conjunction with a once-daily protease inhibitor (PI) (atazanavir, lopinavir or darunavir) and twice daily raltegravir or once daily dolutegravir
- Virologic suppression for \>6 months, defined as plasma viral load (VL) consistently \< 200 copies/mL with no evidence of prior virologic rebound (VL \> 1000 copies/mL) on the NRTI/PI/Raltegravir regimen, AND VL \< 50 copies/mL at time of study screening
- Estimated glomerular filtration rate (eGFR) \> o r= 70mL/min at screening
Exclusion
- Prior documented viral rebound \> 1000 copies/mL on any raltegravir-containing regimen
- Evidence of resistance mutations compromising raltegravir or elvitegravir activity on prior genotypes.
- Evidence of clinically significant resistance to tenofovir on any previous genotype tests: K65R mutation, or 3 or more thymidine-analogue associated mutations (TAMS) compromising tenofovir activity
- Evidence of resistance mutations significantly compromising darunavir activity on any previous genotypic tests
- Current use of any nonnucleoside reverse transcriptase inhibitor (NNRTI)
- Pregnancy or breast-feeding
- Contraindications to tenofovir/FTC, elvitegravir, or cobicistat (e.g. previous significant toxicity, intolerance or drug interactions
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02199613
Start Date
October 1 2014
End Date
February 14 2017
Last Update
November 6 2017
Active Locations (1)
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1
St. Paul's Hospital Immunodeficiency Clinic
Vancouver, British Columbia, Canada, V6Z 1Y6