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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C, Chronic HIV Infection | Drug: Raltegravir Drug: Efavirenz | Phase 4 |
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 |
Actual Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | June 2017 |
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
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Active Comparator: Efavirenz based therapy
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
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Drug: Efavirenz
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Other Name: Sustiva
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- 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.
- 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
- 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
- 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
- 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
- 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
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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