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COMPLETED Phase 4

Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

NCT03512210 · View on ClinicalTrials.gov ↗

Study Summary

To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the \~71 million people with chronic HCV infection will need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has further highlighted the need for innovative models of health care delivery that minimize face-to-face patient-provider contact. The purpose of this study was to evaluate the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy to deliver interferon- and RBV-free, pan-genotypic DAA therapy to treat active HCV in HCV treatment naïve participants.

Interventions

  • DRUG Sofosbuvir/Velpatasvir (SOF/VEL)
  • OTHER Minimal Monitoring (MINMON) Strategy

Study Locations (20)

California

  • University of Southern California (1201) — Los Angeles
  • UCLA CARE Center CRS (601) — Los Angeles
  • Ucsd, Avrc Crs (701) — San Diego
  • Ucsf Aids Crs (801) — San Francisco

New York

  • Weill Cornell Chelsea CRS (7804) — New York
  • Columbia Physicians and Surgeons CRS (30329) — New York
  • Weill Cornell Upton CRS (7803) — New York
  • University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) — Rochester

Illinois

  • Northwestern University CRS (2701) — Chicago
  • Rush Univ. Med. Ctr. ACTG CRS (2702) — Chicago

Massachusetts

  • Massachusetts General Hospital (MGH) CRS (101) — Boston
  • Brigham and Women's Hosp. ACTG CRS (107) — Boston

Alabama

  • Alabama CRS (31788) — Birmingham

Colorado

  • University of Colorado Hospital CRS (6101) — Aurora

District of Columbia

  • Whitman Walker Health CRS (31791) — Washington D.C.

Georgia

  • The Ponce de Leon Center CRS (5802) — Atlanta

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2018-10-22
Est. Completion 2021-02-28
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03512210

The ClinicalTrials.gov registry entry for NCT03512210 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions — of which Sofosbuvir/Velpatasvir (SOF/VEL) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03512210 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, New York, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03512210 about?

NCT03512210 is a clinical study titled "Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection". To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the \~71 million people with chronic HCV infection will need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has...

What is the current status of trial NCT03512210?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2018-10-22. Estimated completion is 2021-02-28.

What conditions does trial NCT03512210 study?

This clinical trial studies the following conditions: Hepatitis C, HIV-1-infection, Liver Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03512210?

The interventions under investigation include: Sofosbuvir/Velpatasvir (SOF/VEL) (DRUG), Minimal Monitoring (MINMON) Strategy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03512210?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03512210 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial