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

Taipei Veterans General Hospital

Status and phase

Completed

Phase 4

Conditions

HIV-1 Infection

Treatments

Drug: Efavirenz

Drug: Raltegravir

Study type

Interventional

Funder types

Other

Identifiers

NCT01989910

TVGH-IRB-2013-07-030B (Other Identifier)

MSD-MISP-39299

Details and patient eligibility

About

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.

Full description

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.

Enrollment

107 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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