Acquired Immunodeficiency Syndrome
Conditions
Interventions
Test Groud:ZL-1
Control Group:ZL-1 placebo
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as HIV/AIDS (according to standard WS293-2008); 2. Aged 16 to 60 years old; 3. Patients who haven't received first-line antiretroviral therapy; 4. HIV RNA= 5000 copies/mL, CD4+=350 cells/µL; 5. Diagnosed as Qi and Yin deficiency syndrome; 6. Attend the study signed the informed consent voluntarily,and complete the visitation.
Exclusion criteria
Exclusion criteria: 1. Acute HIV infection (infection is in half year); 2. Severe opportunistic infection or tumors; 3. WBC2×ULN, TBIL>1×ULN, Cr>1×ULN; 4. HbsAg positive, HBV DNA>2000 IU/ml; Anti-HCV positive and HCV RNA positive; 5. Received other investigational drugs within 3 months; 6. Pregnant or breastfeeding women, and refuse to use regular birth control method during the study; 7. Allergic or intolerant to the trial drug; 8. Serious mental and neurological diseases; 9. Alcoholism ,drug addicts; 10. Patients that are inappropriate base on investigators opinion (those are in poor health or cant follow the visit).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of number that patients’HIV-RNA decrease = 0.5 log/m.; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4+ T cells;Symptoms and signs of traditional Chinese Medicine; | — |
Countries
China
Contacts
Public ContactLu Hongzhou
Shanghai Public Health Clinical Center
Outcome results
None listed