Status:
COMPLETED
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1 Infection
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/...
Eligibility Criteria
Inclusion
- Key
- Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine \[FTC\]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \[NCT02616783\]) for ≥ 3 months
- Documented plasma HIV-1 ribonucleic acid (RNA) \< 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \[NCT02616783\]) for the last 2 visits preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
- Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
- Key
Exclusion
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
- Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2020
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03405935
Start Date
March 1 2018
End Date
May 29 2020
Last Update
December 1 2020
Active Locations (25)
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1
CHU Saint-Pierre
Brussels, Belgium, 1000
2
UZ Gent
Ghent, Belgium, 9000
3
Hopital Saint-Andre
Bordeaux, France, 33075
4
Hopital Europeen Marseille
Marseille, France, 13006