Trial record 16 of 34 for:    " September 30, 2013":" October 30, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Drug: Raltegravir
Drug: Efavirenz
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

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. [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Raltegravir
Raltegravir 400mg oral twice daily
Drug: Efavirenz
Efavirenz 600mg oral at bedtime
Other Name: Stocrit
Active Comparator: Efavirenz
Efavirenz 600mg oral at bedtime
Drug: Raltegravir
Raltegravir 400mg oral twice daily
Other Name: Isentress

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989910

Contacts
Contact: Wing Wai Wong, MD +886-938590783 wwwong@vghtpe.gov.tw

Locations
Taiwan
Division of Infectious Diseases, Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Wing Wai Wong, MD    +886-938590783    wwwong@vghtpe.gov.tw   
Principal Investigator: Wing Wai Wong, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Wing Wai Wong, MD Taipei Veterans General Hospital, Taiwan
  More Information

Publications:
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01989910     History of Changes
Other Study ID Numbers: MSD-MISP-39299, TVGH-IRB-2013-07-030B
Study First Received: October 22, 2013
Last Updated: November 14, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Efavirenz
Raltegravir
Combination antiretroviral therapy

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 29, 2014