Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy

This study is not yet open for participant recruitment.
Verified April 2013 by Peking Union Medical College
Sponsor:
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT01844297
First received: August 24, 2012
Last updated: April 26, 2013
Last verified: April 2013

August 24, 2012
April 26, 2013
May 2013
October 2015   (final data collection date for primary outcome measure)
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01844297 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 count at Week 48 [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 count at Week 96 [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events and laboratory abnormalities from baseline to week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events and laboratory abnormalities from baseline to week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy
Efficacy and Safety of Tenofovir Disoproxil Fumarate Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy for ART-naive Chinese Patients With HIV-1 Infection

This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive Chinese HIV/AIDS patients.

This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.

500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 < 250/μL, and by LPV/r when CD4 > 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb < 90/L or neutrophil count < 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.

The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
AIDS/HIV PROBLEM
Drug: TDF+3TC+EFV
TDF+3TC+EFV
Intervention: Drug: TDF+3TC+EFV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
500
December 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age between 18-65 years of either gender
  • HIV-1 antibody seropositive detected by ELISA and confirmed by western blot
  • CD4 cell count < 500/ul
  • Signed informed consent, with no condition that precludes follow-up for 2 years
  • No plan to move out of the area during the trial
  • antiretroviral therapy naive

Exclusion Criteria:

  • patients in acute phase of HIV infection
  • patients with ongoing opportunistic infection or AIDS-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion
  • patients with the any of the following test results during screening for inclusion:

    • WBC count < 2000/ul,
    • neutrophil count < 1000/ul,
    • Hb < 9g/dl,
    • platelet count < 75000/ul,
    • serum creatinine > 1.5 ULN,
    • transaminases or alkaline phosphatase > 3 ULN,
    • total bilirubin > 2 ULN,
    • serum creatinine kinase > 2 ULN
  • CCr < 60ml/min
  • Pregnancy and breastfeeding
  • Intravenous drug user
  • Severe neuropathy or mental disorder
  • history of alcohol abuse and unable to withdrawal
  • Severe peptic ulcer disease
  • Non-Chinese nationality
Both
18 Years to 65 Years
No
Contact: Tai sheng Li, MD 86-10-69155086 litsh@263.net
China
 
NCT01844297
CACT1215
Yes
LI Taisheng, Peking Union Medical College
Peking Union Medical College
Not Provided
Not Provided
Peking Union Medical College
April 2013

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