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

Phase 4CompletedNCT01989910

Taipei Veterans General Hospital, Taiwan107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

HIV-1 Infection

Interventions

RaltegravirDRUG

Raltegravir 400mg oral twice daily

EfavirenzDRUG

Efavirenz 600mg oral at bedtime

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Infectious Diseases, Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.

Virological response to achieve HIV RNA copies \<20 copies/mL at week 48 of both arms.

Time frame: At week 48 of both arms

Secondary Outcomes

The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.

Virological response to achieve HIV RNA copies \<400 copies/mL at week 48 of both arms.

Time frame: At week 48 of both arms

The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.

The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.

Time frame: At week 48 of both arms.

The Proportion of Treatment Failure at Week 48 for Both Arms.

The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.

Time frame: At week 48 of both arms

Data from ClinicalTrials.gov

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