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

Phase 4

Completed

• Conditions: HIV-1 Infection
• Interventions: Drug: Efavirenz; Drug: Raltegravir

• Registration Number: NCT01989910
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-21
• Primary Completion: 2015-12
• Study Completion: 2017-12
• Status Verified: 2018-10
• Results First Submitted: 2018-10-22
• Results First Submitted QC: 2018-10-22
• Last Update Submitted: 2018-10-22
• Results First Posted: 2019-02-25
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raltegravir	Efavirenz	Raltegravir 400mg oral twice daily
Efavirenz	Raltegravir	Efavirenz 600mg oral at bedtime

Primary Outcome Measures

Name	Time	Method
The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.	At week 48 of both arms	Virological response to achieve HIV RNA copies \<20 copies/mL at week 48 of both arms.

Secondary Outcome Measures

Name	Time	Method
The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.	At week 48 of both arms	Virological response to achieve HIV RNA copies \<400 copies/mL at week 48 of both arms.
The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.	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 Proportion of Treatment Failure at Week 48 for Both Arms.	At week 48 of both arms	The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.

Trial Locations

Locations (1)

Division of Infectious Diseases, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan