Clinical trial NCT01147107: Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
Official title: Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
HIV Infection
Keywords: HIV/HCV co-infection
Antiretroviral therapy
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
name: Viet Tiep Hospital
name: Oxford University Clinical Research Unit, Vietnam
First posted: 2010-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations
timeFrame: over week 72
Secondary outcomes:
Other outcomes:
Locations:
city: Hai Phong
country: Vietnam
facility: Viet Tiep General Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Hospital for Tropical Diseases
Study officials:
affiliation: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
name: Van Vinh Chau Nguyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hawaii - Hawaii Center for AIDS (HICFA)
name: Cecilia M Shikuma, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hawaii, Oxford University Clinical Research Unit
name: Thuy Le, M.D.
role: STUDY_DIRECTOR
References: