Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy
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|ClinicalTrials.gov Identifier: NCT01844297|
Recruitment Status : Unknown
Verified April 2013 by LI Taisheng, Peking Union Medical College.
Recruitment status was: Not yet recruiting
First Posted : May 1, 2013
Last Update Posted : May 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|AIDS/HIV PROBLEM||Drug: TDF+3TC+EFV||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||December 2015|
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844297
|Contact: Tai sheng Li, MDfirstname.lastname@example.org|
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100730|
|Contact: Wei Lv, MD 86-10-69155082 email@example.com|
|Principal Investigator: Taisheng Li, MD|