Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy
The Optimization of HAART for Chinese--a RCT Study
1 other identifier
interventional
184
1 country
3
Brief Summary
Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral therapy in developing countries. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
Started Mar 2018
Shorter than P25 for phase_4 hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedFebruary 18, 2020
February 1, 2020
1.3 years
October 25, 2016
February 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with HIV RNA<50 Copies/ml
48 weeks
Secondary Outcomes (1)
Adverse events
48 weeks
Study Arms (2)
Arm 1
EXPERIMENTALTenofovir 200mg + Lamivudine 300mg +Efavirenz 400mg PO Quaque die
Arm 2
ACTIVE COMPARATORTenofovir 300mg + Lamivudine 300mg +Efavirenz 600mg PO Quaque die
Interventions
Eligibility Criteria
You may qualify if:
- HIV antibody positive
- Chinese nationality
- Naïve to antiretroviral therapy
- Willing to start antiretroviral therapy
- Provision of written informed consent
You may not qualify if:
- Pregnant, breastfeeding, or lactating
- Females try to get pregnant during the research period
- Subjects who allergic to any of the research drugs
- Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
- Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
- Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
- Laboratory blood values:
- Haemoglobin \<9.0 grams/decilitre (g/dL)
- Neutrophil count \<1500/mm3
- Platelet count \<75,000/mm3
- Aspartate aminotransferase or Alanine transaminase \>3 times Upper Limit of Normal (ULN)
- Total bilirubin \>3 times Upper Limit of Normal (ULN)
- Subjects with an estimated creatinine clearance of \<90 mL/minute
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
Yunnan provincial infectious disease hosipital
Kunming, Yunnan, 650041, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 26, 2016
Study Start
March 5, 2018
Primary Completion
June 5, 2019
Study Completion
August 31, 2019
Last Updated
February 18, 2020
Record last verified: 2020-02