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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University of Hawaii
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: October 30, 2013
Last verified: September 2013
  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:


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: December 2013
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
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

Contacts
Contact: Thuy Le, MD 84-8-838-2338

Locations
Vietnam
Viet Tiep General Hospital Not yet recruiting
Hai Phong, Vietnam
Contact: Hoang Dang Mich, PhD MD         
Contact: Pham Hanh Phuc, MD         
Sub-Investigator: Pham Hanh Phuc, M.D.         
Sub-Investigator: Tran Thi Lien         
Sub-Investigator: Pham Van Anh         
Hospital for Tropical Diseases Not yet recruiting
Ho Chi Minh City, Vietnam
Contact: Thuy Le, M.D.    84-8-838 2338      
Principal Investigator: Thuy Le, M.D.         
Sub-Investigator: Thi Kim Cuc Ngo, M.D.         
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

No publications provided

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: October 30, 2013
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Emtricitabine
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 27, 2014