HIV-1 Infection Clinical Trial
— Co-STARsOfficial title:
A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects 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, the HIV/HCV Co-STARs Study (Co-infection Treatment With Single Tablet Antiviral Regimens)
| Verified date | September 2018 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected participants.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | September 29, 2017 |
| Est. primary completion date | September 14, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Clinical Research Puerto Rico Inc | San Juan | |
| United States | Lehigh Valley Health Network, Network Office of Research and Innovation | Allentown | Pennsylvania |
| United States | Clinical Alliance for Research & Education | Annandale | Virginia |
| United States | AIDS Research Consortium of Atlanta | Atlanta | Georgia |
| United States | Emory University | Atlanta | Georgia |
| United States | Central Texas Clinical Research | Austin | Texas |
| United States | Be Well Medical Center | Berkley | Michigan |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | The CORE Foundation | Chicago | Illinois |
| United States | Community AIDS Network | Clearwater | Florida |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Duke University | Durham | North Carolina |
| United States | Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida |
| United States | Therafirst Medical Center | Fort Lauderdale | Florida |
| United States | Midway Immunology & Research Center, LLC | Fort Pierce | Florida |
| United States | East Carolina University | Greenville | North Carolina |
| United States | Gordon E. Crofoot MD PA | Houston | Texas |
| United States | Therapeutics Concepts, PA | Houston | Texas |
| United States | Kansas City Free Health Clinic | Kansas City | Missouri |
| United States | Mills Clinical Research | Los Angeles | California |
| United States | Peter J Ruane MD Inc | Los Angeles | California |
| United States | AIDS Healthcare Foundation | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | AIDS Healthcare Foundation | Miami Beach | Florida |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Saint Michael's Medical Center | Newark | New Jersey |
| United States | Orlando Immunology Center | Orlando | Florida |
| United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Spectrum Medical Group | Phoenix | Arizona |
| United States | University of California Davis | Sacramento | California |
| United States | University of California San Diego | San Diego | California |
| United States | Kaiser Permanente | San Francisco | California |
| United States | Chatham County Health Department | Savannah | Georgia |
| United States | Peter Shalit MD | Seattle | Washington |
| United States | Southern Cal | Spokane | Washington |
| United States | Community Health Care | Tacoma | Washington |
| United States | St. Josephs Comprehensive Research Institute | Tampa | Florida |
| United States | The George Washington University Medical Center | Washington | District of Columbia |
| United States | Whitman-Walker Health | Washington | District of Columbia |
| United States | Triple O Research Institute PA | West Palm Beach | Florida |
| United States | Rowan Tree Medical PA | Wilton Manors | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Puerto Rico,
Huhn G, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/ Emtricitabine/T
Ramgopal M, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/Emtricitabin
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) | Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment. | HCV Posttreatment Week 12 | |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment. | HCV Posttreatment Week 4 | |
| Secondary | Percentage of Participants With HIV-1 RNA = 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm | The percentage of participants with HIV-1 RNA = 50 copies/mL 24 weeks after start of the F/TAF-based regimen were analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | 24 weeks after start of HIV treatment | |
| Secondary | Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | Up to 32 weeks plus 30 days |
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