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

Primary Purpose

Hepatitis C, Chronic, HIV Infection

Status

Completed

Phase

Phase 4

Locations

Vietnam

Study Type

Interventional

Intervention

Raltegravir

Efavirenz

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring HIV/HCV co-infection, Antiretroviral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count < 350 cells/mm3 and/or WHO stage III or IV disease)
Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level
AST and ALT ≤ 2 x ULN (≤ 80 U/L)
Estimated creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

Any prior ART
Positive Hepatitis B surface antigen
Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry
Currently on rifampicin therapy
In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period

Sites / Locations

Viet Tiep General Hospital
Hospital for Tropical Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Raltegravir based therapy

Efavirenz based therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations

To estimate the rates of grade 2*and higher ALT elevations in the two regimens.

Secondary Outcome Measures

Full Information

NCT ID

NCT01147107

First Posted

June 16, 2010

Last Updated

July 21, 2021

Sponsor

University of Hawaii

Collaborators

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Viet Tiep General Hospital, Hai Phong, Vietnam, Oxford University Clinical Research Unit, Vietnam

1. Study Identification

Unique Protocol Identification Number

NCT01147107

Brief Title

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

Official Title

Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

June 1, 2016 (Actual)

Study Completion Date

June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Hawaii

Collaborators

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Viet Tiep General Hospital, Hai Phong, Vietnam, Oxford University Clinical Research Unit, Vietnam

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

The trial will recruit 80 treatment-naive HIV-infected patients with chronic hepatitis C coinfection from two HIV treatment centers in Vietnam. Patients will be randomized to receive either raltegravir or efavirenz, both in combination of tenofovir and emtricitabine, as first-line HIV therapy over a period of 72 weeks. The primary endpoint is the rate of alanine aminotransferase (ALT) elevation during the 72 week study period. Secondary endpoints include rates of virological suppression, CD4 count change, numbers of AIDS events and death, rates of fasting glucose and cholesterol measures, neurocognitive function and levels of immune activation. Patients will be followed monthly for the first 3 months and every 3 months thereafter. At the end of the trial period, patients will be transferred to the National HIV treatment program for continuation of HIV therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic, HIV Infection

Keywords

HIV/HCV co-infection, Antiretroviral therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Raltegravir based therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Efavirenz based therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Raltegravir

Other Intervention Name(s)

Isentress

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Efavirenz

Other Intervention Name(s)

Sustiva

Intervention Description

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

Primary Outcome Measure Information:

Title

Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations

Description

To estimate the rates of grade 2*and higher ALT elevations in the two regimens.

Time Frame

over week 72

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count < 350 cells/mm3 and/or WHO stage III or IV disease) Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level AST and ALT ≤ 2 x ULN (≤ 80 U/L) Estimated creatinine clearance ≥ 60 mL/min Exclusion Criteria: Any prior ART Positive Hepatitis B surface antigen Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding) Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry Currently on rifampicin therapy In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Van Vinh Chau Nguyen, MD, PhD

Organizational Affiliation

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cecilia M Shikuma, M.D.

Organizational Affiliation

University of Hawaii - Hawaii Center for AIDS (HICFA)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thuy Le, M.D.

Organizational Affiliation

University of Hawaii, Oxford University Clinical Research Unit

Official's Role

Study Director

Facility Information:

Facility Name

Viet Tiep General Hospital

City

Hai Phong

Country

Vietnam

Facility Name

Hospital for Tropical Diseases

City

Ho Chi Minh City

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD will be shared with other researchers upon request following the publication of the data. Researchers will contact the PI.

Learn more about this trial

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

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