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

October 22, 2018 updated by: Taipei Veterans General Hospital, Taiwan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Division of Infectious Diseases, Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Raltegravir
Raltegravir 400mg oral twice daily
Drug: Efavirenz
Efavirenz 600mg oral at bedtime
Other Names:
  • Stocrit
Active Comparator: Efavirenz
Efavirenz 600mg oral at bedtime
Drug: Raltegravir
Raltegravir 400mg oral twice daily
Other Names:
  • Isentress

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.
Time Frame: At week 48 of both arms
Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of 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.
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.
At week 48 of both arms.
The Proportion of Treatment Failure at Week 48 for Both Arms.
Time Frame: 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.
At week 48 of both arms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Wing Wai Wong, MD, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSD-MISP-39299
  • TVGH-IRB-2013-07-030B (Other Identifier: TaipeiVGH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV-1 Infection

Clinical Trials on Efavirenz

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe