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

NCT01147107 | Completed Phase 4 Results DMC

• 1 other identifier: VHARP 001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis C, Chronic; HIV Infection

Keywords

HIV/HCV co-infection; Antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  over week 72

Study Arms (2)

Raltegravir based therapy

EXPERIMENTAL

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

Drug: Raltegravir

Efavirenz based therapy

ACTIVE COMPARATOR

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

Drug: Efavirenz

Interventions

Raltegravir DRUG

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

Also known as: Isentress

Raltegravir based therapy

Efavirenz DRUG

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

Also known as: Sustiva

Efavirenz based therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hawaii: lead
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator
• Viet Tiep Hospital: collaborator
• Oxford University Clinical Research Unit, Vietnam: collaborator

Study Sites (2)

Viet Tiep General Hospital

Haiphong, Vietnam

Location

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; HIV Infections

Interventions

Raltegravir Potassium; efavirenz

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Cecilia Shikuma
• Organization: University of Hawaii at Manoa John A Burns School of Medicine

shikuma@hawaii.edu

8086921328

Study Officials

• Van Vinh Chau Nguyen, MD, PhD

  Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

  PRINCIPAL INVESTIGATOR

• Cecilia M Shikuma, M.D.

  University of Hawaii - Hawaii Center for AIDS (HICFA)

  PRINCIPAL INVESTIGATOR

• Thuy Le, M.D.

  University of Hawaii, Oxford University Clinical Research Unit

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2021
• Last Updated: August 13, 2021
• Results First Posted: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

VN (2)