Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy
NCT ID: NCT01844297
Last Updated: 2013-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2013-05-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TDF+3TC+EFV
TDF+3TC+EFV
Interventions
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TDF+3TC+EFV
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Peking Union Medical College
OTHER
Responsible Party
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LI Taisheng
director of the Department of Infectious Disease
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Fan H, Guo F, Hsieh E, Chen WT, Lv W, Han Y, Xie J, Li Y, Song X, Li T. Incidence of hypertension among persons living with HIV in China: a multicenter cohort study. BMC Public Health. 2020 Jun 1;20(1):834. doi: 10.1186/s12889-020-08586-9.
Luo L, Wang N, Yue Y, Han Y, Lv W, Liu Z, Qiu Z, Lu H, Tang X, Zhang T, Zhao M, He Y, Shenghua H, Wang M, Li Y, Huang S, Li Y, Liu J, Tuofu Z, Routy JP, Li T. The effects of antiretroviral therapy initiation time on HIV reservoir size in Chinese chronically HIV infected patients: a prospective, multi-site cohort study. BMC Infect Dis. 2019 Mar 14;19(1):257. doi: 10.1186/s12879-019-3847-0.
Other Identifiers
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CACT1215
Identifier Type: -
Identifier Source: org_study_id
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