HIV Infections
Conditions
Brief summary
The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However, synergy among these drugs has not been well considered. The dose of drugs used as monotherapy is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the first line regimen of cART in developing countries. The side effects of these drugs are related to the concentration of drugs. 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.
Interventions
DRUGTenofovir disoproxil fumarate
Oral daily
DRUGLamivudine
Oral daily
DRUGEfavirenz
Oral daily
Sponsors
Yunnan Provincial Infectious Disease Hospital
The Second Hospital of Nanjing Medical University
Shanghai Public Health Clinical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HIV antibody positive * Chinese nationality * Naïve to antiretroviral therapy * Willing to start antiretroviral therapy * Provision of written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with HIV viral road < 50 copies/ml | 48 weeks | calculate the percentage of patients who with HIV viral road \<50 copies/ml every month in two groups |
Secondary
| Measure | Time frame |
|---|---|
| Cell Differentiation 4 (CD4) T cell counts | 48 weeks |
Other
| Measure | Time frame |
|---|---|
| The incidence of adverse events | 48 weeks |
Countries
China
Outcome results
None listed