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
Public ClinicalTrials.gov record NCT02707601. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02707601
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2016 (Actual)
- Primary completion
- Sep 14, 2017 (Actual)
- Completion
- Sep 29, 2017 (Actual)
- Last update posted
- Nov 14, 2018
2016 – 2017
United States locations
- U.S. sites
- 42
- U.S. states
- 16
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | — | — |
| Spectrum Medical Group | Phoenix | Arizona | — | — |
| Mills Clinical Research | Los Angeles | California | — | — |
| Peter J Ruane MD Inc | Los Angeles | California | — | — |
| University of California Davis | Sacramento | California | — | — |
| University of California San Diego | San Diego | California | — | — |
| Kaiser Permanente | San Francisco | California | — | — |
| The George Washington University Medical Center | Washington D.C. | District of Columbia | — | — |
| Whitman-Walker Health | Washington D.C. | District of Columbia | — | — |
| Community AIDS Network | Clearwater | Florida | — | — |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | — | — |
| Therafirst Medical Center | Fort Lauderdale | Florida | — | — |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | — | — |
| University of Miami | Miami | Florida | 33136 | — |
| AIDS Healthcare Foundation | Miami | Florida | — | — |
| AIDS Healthcare Foundation | Miami Beach | Florida | — | — |
| Orlando Immunology Center | Orlando | Florida | — | — |
| St. Josephs Comprehensive Research Institute | Tampa | Florida | — | — |
| Triple O Research Institute PA | West Palm Beach | Florida | — | — |
| Rowan Tree Medical PA | Wilton Manors | Florida | — | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | — | — |
| Emory University | Atlanta | Georgia | — | — |
| Chatham County Health Department | Savannah | Georgia | — | — |
| The CORE Foundation | Chicago | Illinois | — | — |
| Be Well Medical Center | Berkley | Michigan | — | — |
| Kansas City Free Health Clinic | Kansas City | Missouri | — | — |
| Saint Michael's Medical Center | Newark | New Jersey | — | — |
| Weill Cornell Medical College | New York | New York | — | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | — | — |
| Duke University | Durham | North Carolina | — | — |
| East Carolina University | Greenville | North Carolina | — | — |
| Lehigh Valley Health Network, Network Office of Research and Innovation | Allentown | Pennsylvania | — | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | — | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | — | — |
| Central Texas Clinical Research | Austin | Texas | — | — |
| UT Southwestern Medical Center | Dallas | Texas | — | — |
| Gordon E. Crofoot MD PA | Houston | Texas | — | — |
| Therapeutics Concepts, PA | Houston | Texas | — | — |
| Clinical Alliance for Research & Education | Annandale | Virginia | — | — |
| Peter Shalit MD | Seattle | Washington | — | — |
| Southern Cal | Spokane | Washington | — | — |
| Community Health Care | Tacoma | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02707601, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 14, 2018 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02707601 live on ClinicalTrials.gov.