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

HIV-1 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989910
• Other study ID #: MSD-MISP-39299
• Secondary ID: TVGH-IRB-2013-07
• Status: Completed
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: October 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• HIV-1 Infection
• Infection

Intervention

Drug:
• Raltegravir
Raltegravir 400mg oral twice daily
• Efavirenz
Efavirenz 600mg oral at bedtime

Locations

Country	Name	City	State
Taiwan	Division of Infectious Diseases, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & 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. Erratum in: Lancet. 2009 Dec 19-2010 Jan 1;374(9707):2054. Lancet. 2009 Sep 5;374(9692):786. — View 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. — View 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-naïve 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At week 48 of both arms
Secondary	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.	At week 48 of both arms.
Secondary	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.	At week 48 of both arms