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Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection

NCT01147107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-08-13

Study results available
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Summary

The main objective is to evaluate the hepatic safety of raltegravir when compared to efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment in patients with HIV and hepatitis C coinfection.

Conditions

  • Hepatitis C, Chronic
  • HIV Infection

Interventions

DRUG

Raltegravir

Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily

DRUG

Efavirenz

Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily

Sponsors & Collaborators

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Viet Tiep Hospital

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    collaborator OTHER

  • University of Hawaii

    lead OTHER

Principal Investigators

  • Van Vinh Chau Nguyen, MD, PhD · Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

  • Cecilia M Shikuma, M.D. · University of Hawaii - Hawaii Center for AIDS (HICFA)

  • Thuy Le, M.D. · University of Hawaii, Oxford University Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-06-01
Completion
2021-06-01

Countries

  • Vietnam

Study Locations

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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 NCT01147107 on ClinicalTrials.gov