---
title: "Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study"
nct_id: NCT02220868
overall_status: COMPLETED
phase: PHASE4
sponsor: "Saint Michael's Medical Center"
study_type: INTERVENTIONAL
primary_condition: Hepatitis C Infection
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02220868.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02220868"
ct_last_update_post_date: 2016-08-04
last_seen_at: "2026-05-12T06:03:45.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study

**NCT ID:** [NCT02220868](https://clinicaltrials.gov/study/NCT02220868)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Saint Michael's Medical Center
- **Conditions:** Hepatitis C Infection, HIV Infection
- **Start Date:** 2014-07
- **Completion Date:** 2015-09
- **CT.gov Last Update:** 2016-08-04

## Brief Summary

The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.

## Detailed Description

The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 18 years of age or older
* Chronic HCV genotype 1 infection
* Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
* CD4 count \>200 cells/mm3 at screening and no CD4 count \<200 in previous 12 weeks
* HIV RNA PCR \<50 copies/ml at screening and no HIV RNA PCR \> 200 copies/ml in previous 12 weeks

Exclusion Criteria:

* History of integrase inhibitor resistance
* History of integrase inhibitor failure
* Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans \<1200/mm3
* Patients with cirrhosis
* Platelet count under 90,000 per cubic millimeter
* Hemoglobin levels \<11 gm/dl in women or \<12 gm/dl in men
* Previous treatment with a DAA
* Hepatocellular carcinoma
* AFP\>100 ng/mL
* hepatitis B virus (HBsAg positive)
* Evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
```

## Arms

- **Sofossbuvir, Riabvirin, Stribild** (OTHER) — Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild

## Interventions

- **Sofosbuvir, Ribavirin, and Stribild** (DRUG)

## Primary Outcomes

- **• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy** _(time frame: 12 weeks post treatment)_ — patients who have achieved non-detectable HCV levels 12 weeks post treatment

## Locations (1)

- Saint Michael's Medical Center, Newark, New Jersey, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.saint michael's medical center|newark|new jersey|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02220868.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02220868*  
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