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NCT03512210 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Hepatitis C and HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

Completed
Registry status
Phase 4
Development phase
400
Enrollment target
20
Study locations

NCT03512210: Completed Phase 4 study of Hepatitis C and HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

NCT03512210 is a Phase 4 study of Hepatitis C and HIV-1-infection that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 400 participants, below the 1,886-participant average among 106 other Hepatitis C trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03512210, a Phase 4 study of Hepatitis C and HIV-1-infection, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

COMPLETED
Registry status
Phase 4
Development phase
400 participants
Enrollment target
20
Study locations

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.

Primary Outcome

SVR12 was defined as plasma HCV RNA less than the lower limit of quantification (LLOQ) from the earliest sample drawn at least 22 weeks following study treatment initiation (i.e. at a visit scheduled at least 10 weeks after scheduled end of study treatment). Participants without any HCV RNA result at least 22 weeks after treatment initiation will be considered as having HCV RNA greater than the LLOQ. LLOQ was defined as \<15 IU/mL for results tested at USA centralized testing laboratory Quest u

Conditions Studied

Hepatitis C HIV-1-infection Liver Diseases

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
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

45 total trials

What the finished NCT03512210 record still lists

NCT03512210 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,886-participant average among 106 other Hepatitis C trials with a reported enrollment target (79% lower).

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.

NCT03512210 names 20 study sites across 12 states, led by California, New York, Illinois.

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.

What interventions are being tested in trial NCT03512210?

The interventions under investigation include: Sofosbuvir/Velpatasvir (SOF/VEL) (DRUG), Minimal Monitoring (MINMON) Strategy (OTHER).

Who is sponsoring clinical trial NCT03512210?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Hepatitis C

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03512210's enrollment target sits among peer trials

400 28th of 106 higher than 79 of 106 other Hepatitis C trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03512210, the US trial registry maintained by the National Library of Medicine. NCT03512210 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.