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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Viet Tiep General Hospital, Hai Phong, Vietnam

Oxford University Clinical Research Unit, Vietnam

Information provided by (Responsible Party):

University of Hawaii

ClinicalTrials.gov Identifier:

NCT01147107

First received: June 16, 2010

Last updated: March 11, 2016

Last verified: March 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hepatitis C, Chronic HIV Infection	Drug: Raltegravir Drug: Efavirenz	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Emtricitabine Tenofovir Efavirenz Raltegravir Raltegravir potassium

U.S. FDA Resources

Further study details as provided by University of Hawaii:

Primary Outcome Measures:

Rates of Grade 2 and higher alanine aminotransferase (ALT) elevations [ Time Frame: over week 72 ] [ Designated as safety issue: Yes ]
To estimate the rates of grade 2*and higher ALT elevations in the two regimens.

Secondary Outcome Measures:

Plasma HIV RNA </= 150 copies/mL by the Abbot M2000 platform [ Time Frame: 24 weeks and 72 weeks ] [ Designated as safety issue: Yes ]
To estimate rates of HIV virologic suppression at week 24 and week 72
Change in CD4 count [ Time Frame: from entry to week 24, from entry to week 72 ] [ Designated as safety issue: Yes ]
To assess changes in CD4 counts from entry to week 24 and week 72
Time to death and/or occurrence of new or recurrent AIDS-defining events [ Time Frame: entry to week 24, entry to week 72 ] [ Designated as safety issue: Yes ]
To examine time to death and/or occurrence of new or recurrent AIDS-defining events
Changes in fasting blood glucose and cholesterol measures [ Time Frame: entry to week 24, entry to week 72 ] [ Designated as safety issue: Yes ]
To examine changes in fasting blood glucose and cholesterol measures
Changes in monocyte and T cell immune activation [ Time Frame: entry to week 24, entry to week 48 ] [ Designated as safety issue: No ]
To study changes in levels of immune activation in monocytes and T cells from entry to week 24 and week 72 and assess relationship with clinical, immunological and virological outcomes
Neurocognitive function [ Time Frame: entry to week 24, entry to week 72 ] [ Designated as safety issue: No ]
To evaluate the neurocognitive function of HIV and hepatitis C (HCV) coinfected subjects undergoing antiretroviral therapy (ART)


Estimated Enrollment:	80
Study Start Date:	February 2014
Estimated Study Completion Date:	June 2017
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Raltegravir based therapy Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily	Drug: Raltegravir Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily Other Name: Isentress
Active Comparator: Efavirenz based therapy Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily	Drug: Efavirenz Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily Other Name: Sustiva

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147107

Locations


Vietnam
Viet Tiep General Hospital
Hai Phong, Vietnam
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam

Sponsors and Collaborators

University of Hawaii

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Viet Tiep General Hospital, Hai Phong, Vietnam

Oxford University Clinical Research Unit, Vietnam

Investigators


Principal Investigator:	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)
Study Director:	Thuy Le, M.D.	University of Hawaii, Oxford University Clinical Research Unit

More Information


Responsible Party:	University of Hawaii
ClinicalTrials.gov Identifier:	NCT01147107 History of Changes
Other Study ID Numbers:	VHARP 001
Study First Received:	June 16, 2010
Last Updated:	March 11, 2016
Health Authority:	United States: Institutional Review Board Vietnam: The Ministry of Health

Keywords provided by University of Hawaii:


HIV/HCV co-infection Antiretroviral therapy

Additional relevant MeSH terms:


Hepatitis Hepatitis C HIV Infections Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes	Immune System Diseases Hepatitis, Chronic Tenofovir Raltegravir Potassium Efavirenz Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on September 23, 2016

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