ART Drug Dosage Adjustment in HIV-infected Population
This trial is active, not recruiting.
|Sponsor||Shanghai Public Health Clinical Center|
|Start date||April 2015|
|End date||December 2016|
|Trial size||10 participants|
|Trial identifier||NCT02632474, FSCII-ART-1|
The purpose of this study is to determine efficacy of the combination of low dose of Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
HIV viral load
time frame: 48 weeks
time frame: 48 weeks
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - HIV antibody positive - HIV RNA below 10*E5 copies/ml - CD4 T cell count above 200 cells/ml - Provision of written informed consent Exclusion Criteria: - HIV genotyping resistant to investigating drug - Pregnant, breastfeeding, or lactating - 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 <7.0 grams/decilitre (g/dL) - Neutrophil count <500/mm3 - Platelet count <50,000/mm3 - Aspartate aminotransferase or Alanine transaminase >5 times Upper Limit of Normal (ULN) - Subjects with an estimated creatinine clearance of <50 mL/minute
|Official title||ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population|
|Description||The feedback system control (FSC) technique has been developed to rapidly identify optimal combinations for therapeutic purposes. Low dose of TDF+3TC+EFV combination has been test in vitro study by FSC which showed high efficacy and now the investigators apply it to human to further optimize the ART combination.|
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