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

• 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.
  
  

• 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)
  
  

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.