ART Drug Dosage Adjustment in HIV-infected Population
Phase 4
Completed
- Conditions
- HIV Infections
- Interventions
- Drug: Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
- Registration Number
- NCT02632474
- Lead Sponsor
- Shanghai Public Health Clinical Center
- Brief Summary
The purpose of this study is to determine efficacy of the combination of low dose of Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Low-dose Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV) Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
- Primary Outcome Measures
Name Time Method HIV viral load 48 weeks
- Secondary Outcome Measures
Name Time Method CD4 Count 48 weeks
Trial Locations
- Locations (1)
Shanghai Public Health Clinical Center
🇨🇳Shanghai, Shanghai, China