Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment (Co-STARs)
HIV-1 Infection, HCV Infection
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring HIV, HCV, Antiretroviral therapy, HCV direct acting antiviral(s) (DAA)
Eligibility Criteria
Key Inclusion Criteria:
- Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female individuals, without cirrhosis, treatment-naive or treatment-experienced with interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI).
- Compensated cirrhotic individuals must be HCV treatment-naive.
- No prior treatments with NS5A and NS5B or any HCV direct acting antivirals, except boceprevir, telaprevir and simeprevir, in combination with IFN and RBV
- Currently on an ARV regimen (2 NRTI + a third agent) without change for 6 months prior to screening.
- Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values ("blips") of HIV-1 RNA ≥ 50 copies/mL followed by resuppression is allowed.
For individuals with 3 or more prior ARV regimens, a regimen history should be provided for approval by the Sponsor.
- Note: Individuals that changed from TDF to TAF less than 6 months ago will be eligible as long as the TDF/ TAF change was the only change to the regimen.
- Plasma HIV-1 RNA level < 50 copies/mL at the screening visit
- Have no documented resistance to any of the HIV study agents at time in the past, including but not limited to the reverse transcriptase resistance mutations K65R, K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L, the combination of K103N+L100I, or 3 or more thymidine analog associated mutations (TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). If a historical genotype prior to first ARV is not available or individual had 3 or more prior ARV regimens, individual will have proviral genotype analysis for archived resistance prior to Day 1.
- No history of HIV virologic failure
- No evidence of Hepatitis B infection
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min as estimated by Cockcroft-Gault formula
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Sites / Locations
- University of Alabama at Birmingham
- Spectrum Medical Group
- Mills Clinical Research
- Peter J Ruane MD Inc
- University of California Davis
- University of California San Diego
- Kaiser Permanente
- The George Washington University Medical Center
- Whitman-Walker Health
- Community AIDS Network
- Gary Richmond, MD, PA, Inc.
- Therafirst Medical Center
- Midway Immunology & Research Center, LLC
- AIDS Healthcare Foundation
- University of Miami
- AIDS Healthcare Foundation
- Orlando Immunology Center
- St. Josephs Comprehensive Research Institute
- Triple O Research Institute PA
- Rowan Tree Medical PA
- AIDS Research Consortium of Atlanta
- Emory University
- Chatham County Health Department
- The CORE Foundation
- Be Well Medical Center
- Kansas City Free Health Clinic
- Saint Michael's Medical Center
- Weill Cornell Medical College
- University of North Carolina at Chapel Hill
- Duke University
- East Carolina University
- Lehigh Valley Health Network, Network Office of Research and Innovation
- Philadelphia FIGHT
- University of Pennsylvania
- Central Texas Clinical Research
- UT Southwestern Medical Center
- Gordon E. Crofoot MD PA
- Therapeutics Concepts, PA
- Clinical Alliance for Research & Education
- Peter Shalit MD
- Southern Cal
- Community Health Care
- Clinical Research Puerto Rico Inc
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
E/C/F/TAF + LDV/SOF
F/R/TAF + LDV/SOF
Part 1: Participants will switch from 2 nucleoside reverse transcriptase inhibitors (NRTI) plus a third agent to E/C/F/TAF. Part 2: After 8 weeks of E/C/F/TAF treatment, the participants maintaining HIV-1 RNA < 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study.
Part 1: Participants will switch from 2 NRTI plus a third agent to F/R/TAF. Part 2: After 8 weeks of F/R/TAF treatment, the participants maintaining HIV-1 RNA < 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study.