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HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection

NCT02660905 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-11-14

No results posted yet for this study

Summary

This is an prospective open label pilot study conducted over 32 weeks.

A total of 25 eligible participants who are infected with HCV and HIV will be recruited from 2 Canadian HIV Trials Network (CTN) sites (Ottawa Hospital Research Institute and McGill University Health Centre)

This study is investigating the effectiveness of a combination of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen (E/C/F/TAF STR) for HIV treatment and Harvoni for HCV treatment.

This study will assess the effect that the study drug has on the metabolism of sugar, the changes in fat in the bloodstream, and other metabolic changes. Metabolism is the process your body uses to get or make energy from the food you eat.

This study may provide information on the impact of liver fibrosis (scarring of liver tissues) on metabolic changes before, during and after HCV antiviral therapy.

Drug-drug interactions (DDI) between E/C/F/TAF and LPV-SOF have been well evaluated and no clinically significant interactions have been identified.

A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be particularly beneficial because of its:

1. favorable side effect profile
2. once daily STR formulation
3. known DDI profile with LPV-SOF
4. neutral effect on liver fibrosis
5. improved kidney and bone safety profile with the use of TAF

Conduct of this study is justified as it:

1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and HCV using well tolerated medications with an excellent safety profile and known DDI profile.
2. Provides additional safety data for TAF in the HIV-HCV co-infected population.
3. Quantifies adherence and identifies obstacles to full adherence in this population. There is a paucity of data related to DAA adherence in licensing studies.
4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF DAA therapy in HIV-HCV co-infected populations.
5. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance in HIV-HCV co-infection
6. As a pilot study, the information gathered will inform the feasibility of future clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.

Conditions

  • Human Immunodeficiency Virus
  • Hepatitis C, Chronic

Interventions

DRUG

E/C/F/TAF;

Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy

DRUG

Ledipasvir-Sofosbuvir

Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Curtis Cooper, MD, FRCPC · The Ottawa Hospital; Ottawa Hospital Research Institute

  • Marina Klein, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-01-31
Completion
2018-06-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02660905 on ClinicalTrials.gov