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

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ClinicalTrials.gov Identifier: NCT01147107
Recruitment Status : Active, not recruiting
First Posted : June 22, 2010
Last Update Posted : March 8, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic HIV Infection Drug: Raltegravir Drug: Efavirenz Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2014
Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Rates of Grade 2 and higher alanine aminotransferase (ALT) elevations [ Time Frame: over week 72 ]
    To estimate the rates of grade 2*and higher ALT elevations in the two regimens.


Secondary Outcome Measures :
  1. Plasma HIV RNA </= 150 copies/mL by the Abbot M2000 platform [ Time Frame: 24 weeks and 72 weeks ]
    To estimate rates of HIV virologic suppression at week 24 and week 72

  2. Change in CD4 count [ Time Frame: from entry to week 24, from entry to week 72 ]
    To assess changes in CD4 counts from entry to week 24 and week 72

  3. Time to death and/or occurrence of new or recurrent AIDS-defining events [ Time Frame: entry to week 24, entry to week 72 ]
    To examine time to death and/or occurrence of new or recurrent AIDS-defining events

  4. Changes in fasting blood glucose and cholesterol measures [ Time Frame: entry to week 24, entry to week 72 ]
    To examine changes in fasting blood glucose and cholesterol measures

  5. Changes in monocyte and T cell immune activation [ Time Frame: entry to week 24, entry to week 48 ]
    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

  6. Neurocognitive function [ Time Frame: entry to week 24, entry to week 72 ]
    To evaluate the neurocognitive function of HIV and hepatitis C (HCV) coinfected subjects undergoing antiretroviral therapy (ART)


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared with other researchers upon request following the publication of the data. Researchers will contact the PI.

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
Emtricitabine
Efavirenz
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