HIV Infections
Conditions
Keywords
HIV Infections, Tenofovir, Efavirenz
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.
Interventions
DRUGTenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
The first 2 weeks, TDF (300 mg) + 3-TC (300 mg) + EFV (400 mg); week 3, TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg ); week 4, TDF (150 mg) + 3-TC (300 mg) + EFV (400 mg).From week5, if the HIV viral load decreased as expected or no rebound, use TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg) until study complete; if the viral load increases, switch to the standard treatment regimen: TDF (300 mg) + 3-TC (300 mg) + EFV (600 mg).
Sponsors
Shanghai Public Health Clinical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV viral load | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| CD4 Count | 48 weeks |
Other
| Measure | Time frame |
|---|---|
| Drug Plasma Concentration | Day 7,14,21,28 |
Countries
China
Outcome results
None listed