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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by LI Taisheng, Peking Union Medical College.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01844297
First Posted: May 1, 2013
Last Update Posted: May 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College
August 24, 2012
May 1, 2013
May 1, 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 ]
Same as current
No Changes Posted
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ]
  • Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96 [ Time Frame: 96 weeks ]
  • Change From Baseline in CD4 count at Week 48 [ Time Frame: Baseline and 48 weeks ]
  • Change From Baseline in CD4 count at Week 96 [ Time Frame: Baseline and 96 weeks ]
  • Incidence of adverse events and laboratory abnormalities from baseline to week 48 [ Time Frame: 48 weeks ]
  • Incidence of adverse events and laboratory abnormalities from baseline to week 96 [ Time Frame: 96 weeks ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01844297
CACT1215
Yes
Not Provided
Not Provided
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
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