Status:
UNKNOWN
Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy
Lead Sponsor:
Peking Union Medical College
Conditions:
AIDS/HIV PROBLEM
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 Chi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01844297
Start Date
May 1 2013
End Date
December 1 2015
Last Update
May 1 2013
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730