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Clinical study of ZL-1 with HIV infected or AIDS(Version.2)

Clinical study of ZL-1 with HIV infected or AIDS(Version.2)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012045
Enrollment
Unknown
Registered
2017-07-19
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS

Interventions

Test Group:ZL-1 and HARRT
Control Group:ZL-1 placebo and HARRT

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

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. Participant aged 16 to 60 years old; 3. Accepted ART treatment over 12 months,and HIV-RNA< 50 copies/mL last than 12 months; 4. HIV-RNA < 50 copies/mL and CD4+< 200 cells/uL; 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. Severe opportunistic infection or tumors; 2. WBC2×ULN,TBIL>1×ULN,Cr>1×ULN; 3. Received other investigational drugs within 3 months; 4. HbsAg positive,HBV DNA>2000 IU/ml; Anti-HCV positive and HCV RNA positive; 5. Pregnant or breastfeeding women, and refuse to use regular birth control method during the study; 6. Allergic or intolerant to the trial drug; 7. Serious mental and neurological diseases; 8. Alcoholism ,drug addicts; 9. Patients that are inappropriate base on investigators opinion( those are in poor health or cant follow the visit).

Design outcomes

Primary

MeasureTime frame
Percent of patients that CD4+Cells=30%;

Secondary

MeasureTime frame
CD4+/CD8+;HIV-RNA;Symptoms and signs of traditional Chinese Medicine;

Countries

China

Contacts

Public ContactLu Hongzhou

Shanghai Public Health Clinical Center

luhongzhou@fudan.edu.cn+86 18930810088

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026