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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Taipei Veterans General Hospital, Taiwan
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01989910
First received: October 22, 2013
Last updated: November 14, 2013
Last verified: November 2013

October 22, 2013
November 14, 2013
September 2013
September 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms.
Same as current
Complete list of historical versions of study NCT01989910 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: At week 48 of both arms. ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: At week 48 of both arms ] [ Designated as safety issue: Yes ]
    The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.
Same as current
Not Provided
Not Provided
 
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
  • Drug: Raltegravir
    Raltegravir 400mg oral twice daily
    Other Name: Isentress
  • Drug: Efavirenz
    Efavirenz 600mg oral at bedtime
    Other Name: Stocrit
  • Active Comparator: Raltegravir
    Raltegravir 400mg oral twice daily
    Intervention: Drug: Efavirenz
  • Active Comparator: Efavirenz
    Efavirenz 600mg oral at bedtime
    Intervention: Drug: Raltegravir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2016
September 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact: Wing Wai Wong, MD +886-938590783 wwwong@vghtpe.gov.tw
Taiwan
 
NCT01989910
MSD-MISP-39299, TVGH-IRB-2013-07-030B
No
Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
Not Provided
Principal Investigator: Wing Wai Wong, MD Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP