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

Primary Purpose

HIV-1 Infection

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Raltegravir
Efavirenz
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection focused on measuring Efavirenz, Raltegravir, Combination antiretroviral therapy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Infectious Diseases, Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Raltegravir

Efavirenz

Arm Description

Raltegravir 400mg oral twice daily

Efavirenz 600mg oral at bedtime

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 22, 2013
Last Updated
October 22, 2018
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01989910
Brief Title
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection
Keywords
Efavirenz, Raltegravir, Combination antiretroviral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raltegravir
Arm Type
Active Comparator
Arm Description
Raltegravir 400mg oral twice daily
Arm Title
Efavirenz
Arm Type
Active Comparator
Arm Description
Efavirenz 600mg oral at bedtime
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Other Intervention Name(s)
Isentress
Intervention Description
Raltegravir 400mg oral twice daily
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Other Intervention Name(s)
Stocrit
Intervention Description
Efavirenz 600mg oral at bedtime
Primary Outcome Measure Information:
Title
The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.
Description
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 Outcome Measure Information:
Title
The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.
Description
Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms.
Time Frame
At week 48 of both arms
Title
The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.
Description
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.
Title
The Proportion of Treatment Failure at Week 48 for Both Arms.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing Wai Wong, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Infectious Diseases, Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19647866
Citation
Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. doi: 10.1016/S0140-6736(09)60918-1. Epub 2009 Aug 3. Erratum In: Lancet. 2009 Dec 19-2010 Jan 1;374(9707):2054. Lancet. 2009 Sep 5;374(9692):786.
Results Reference
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PubMed Identifier
20085491
Citation
Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
Results Reference
background
PubMed Identifier
21126956
Citation
Young B, Vanig T, Dejesus E, Hawkins T, St Clair M, Yau L, Ha B, Shield Study Team. A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naive HIV-1-infected patients: 48-week results of the SHIELD trial. HIV Clin Trials. 2010 Sep-Oct;11(5):260-9. doi: 10.1310/hct1105-260.
Results Reference
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Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

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