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

NCT01989910 | Completed Phase 4 Results

• 2 other identifiers: MSD-MISP-39299TVGH-IRB-2013-07-030B
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1 Infection

Keywords

Efavirenz; Raltegravir; Combination antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  At week 48 of both arms

Secondary Outcomes (3)

• 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

• 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.

  At week 48 of both arms

Study Arms (2)

Raltegravir

ACTIVE COMPARATOR

Raltegravir 400mg oral twice daily

Drug: Efavirenz

Efavirenz

ACTIVE COMPARATOR

Efavirenz 600mg oral at bedtime

Drug: Raltegravir

Interventions

Raltegravir DRUG

Raltegravir 400mg oral twice daily

Also known as: Isentress

Efavirenz

Efavirenz DRUG

Efavirenz 600mg oral at bedtime

Also known as: Stocrit

Raltegravir

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Division of Infectious Diseases, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 19647866 BACKGROUND

• 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.

  PMID: 20085491 BACKGROUND

• 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.

  PMID: 21126956 BACKGROUND

MeSH Terms

Interventions

Raltegravir Potassium; efavirenz

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. WEN-WEI KU
• Organization: Taipei Veterans General Hospital

stephaneku@gmail.com

+886228751997

Study Officials

• Wing Wai Wong, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 21, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: February 25, 2019
• Results First Posted: February 25, 2019

Record last verified: 2018-10

Locations

TW (1)