Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection

A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.

A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.

Inclusion Criteria:

• Patients who are infected with HIV-1
• Patients have not yet received any treatment for HIV
• Patients with HIV viral RNA exceeds 5000 copies per ml
• Ages at least 20 years

Exclusion Criteria:

• Patients with acute or decompensated chronic hepatitis
• Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range
• Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
• Patients with any medical disorder that the use of study medications is contraindicated
• Pregnant or breastfeeding women
• Patients who are lack of expectation to maintain assigned study medication during study period
• Patients who have received therapy with investigational drugs in the previous 3 months