HIV/AIDS
Conditions
Interventions
Treatment group:LFnp24B.C
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Volunteers infected with HIV-1 who has received ART for equal or above 24 months with initial CD4 count above 200 cells/uL when ART initiated; 2. Viral load remains below 50 copies/mL after receiving ART for six months, tested at least twice with at least 3 months apart, (COBAS AmpliPrep/COBAS TaqMan HIV-1TEST), with complete immune reconstitution; 3. CD4 count >= 500 cells/µL prior to entry; 4. Stated willingness to tell their identity and follow visit; 5. Two weeks before the first injection and during the clinical trial, they are willing to take effective contraceptive measures with their sexual partners. Women of childbearing age are willing to undergo urine pregnancy test before vaccination and at each follow-up; 6. Stated understanding the trial and willingness to sign the written informed consent; 7. Adult male or female aged 18–60 years.
Exclusion criteria
Exclusion criteria: 1. Volunteers who are positive against pregnant testing within 7 days prior to entry or who are breastfeeding or with intent to conceive during the study duration; 2. Prior participation in any HIV-1 vaccine trial or recipient of HIV-related immunogenic materials within 5 years prior to the study entry; 3. Vaccination of attenuated live vaccine, inactivated vaccine, subunit vaccine and anti-allergy therapy, or other testing drug or cell therapy within 30 days of study entry; 4. Vaccination of anthrax vaccine or experienced with anthrax infection; 5. Acute or chronic viral hepatitis; 6. Receipt of blood products, immunoglobulin or immunotherapy within 12 weeks of study entry; 7. Suspected TB or ongoing anti-TB treatment or with abnormal CT scan of chest. 8. A history of serious adverse reactions, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and abdominal pain, following administration of any vaccines, or a history of hypersensitivity specifically to any components of study vaccine. 9. Active opportunistic infection or malignancy requiring systemic therapy within 60 days of study entry or likely to require systemic therapy during the study, or any acute medical condition that in the opinion of the investigator may obscure the ability to observe the safety or activity of the study vaccine treatment; 10. Active alcohol or drug user or with a mental or psychiatric condition; 11. Patients with a history of HIV dementia or progressive multifocal leukoencephalopathy (PML); 12. Drug resistance to two or more component of ATR regimen; 13. Patients with severe cardiovascular diseases such as myocardial infarction, heart failure, severe chronic kidney diseases such as uremia, and malignant tumors; 14. If one or more of laboratory values of blood chemistry testing is as the following 14 days prior to entry: Hemoglobin 1.0 ULN; ALT or AST > 2.5 ULN; Total bilirubin >1.5 ULN; Alkaline phosphatase > 2.5 ULN; 15. Other inappropriate factors judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile;Occurrence of HIV RNA rebound after ATI;Magnitude of HIV RNA rebound after ATI;Timepoint of HIV RNA rebound after ATI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Humoral immunity;Cell-mediate immunity;HIV reservoir; | — |
Countries
China
Contacts
Public ContactZhu Biao
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed