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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Efavirenz; Raltegravir Potassium

Criteria

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