HIV
Conditions
Interventions
Treatment Group:ABT 640mg, administered every 4 weeks, intravenous drip
Sponsors
Guiyang public treatment center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The subjects need to meet all of the following inclusion criteria: 1. Age = 18 years old; 2. No gender limit; 3. HIV-1 antibody confirmation test positive ; 4. Stable and continuous acceptance of the currently used antiretroviral protocol (excluding ABT) for more than 3 months, and the previous protocol or drug conversion was not due to Virology failure; -The conversion between the following individual antiretroviral drugs is not considered a conversion of the ART protocol: a. Protease inhibitor (PI)/Ritonavir converted to isoprotease inhibitor combined with cobistat (or vice versa) b. Lamivudine (3TC) is converted to Emtricitabine (and vice versa) c. Conversion of tenofovir fumarate (TDF) to Tenofovir alafenamide fumarate (and vice versa) 5. The measured value of plasma HIV-1 RNA within the 12 months before screening is less than 50 copies/mL. If the reported date of this measurement is within 6 months before the screening period, the previous plasma HIV-1 RNA measurement must also be less than 50 copies/mL; 6. During screening, plasma HIV-1 RNA<50 copies/mL; 7. Before proceeding with any steps related to this study, understand and sign the informed consent form and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Individuals with known DTG, ABT resistance, or allergies to related drug components; 2. Women who are pregnant, breastfeeding, or have a family plan; 3. Those who have clinically observed evidence of opportunistic infectious disease and are at stage 3 according to the American CDC HIV infection rating [11] (in which the previous or current CD4 T cell count<200/uL is not included); 4. Those who meet the C-level criteria for severe liver function damage according to the Child Pugh classification criteria; 5. There is clear evidence of HBV infection; 6. Those who need to receive anti HCV treatment; 7. Ongoing progress of malignant tumors, including but not limited to Kaposi's sarcoma of the skin, basal cell tumor, non-invasive resected cutaneous squamous cell carcinoma or intraepithelial neoplasia of the cervix, anus and penis; 8. Untreated syphilis infected individuals (excluding those who have completed a complete treatment cycle for syphilis for at least 7 days); 9. According to the judgment of the researcher, there is a clear tendency to commit suicide; 10. According to the judgment of the investigator, there are any physical or mental abnormalities that may affect the drug treatment, Program evaluation or the safety of the subject in the past; 11. Current drug users; 12. Patients with severe mental and neurological disorders; 13. Those who have a history of alcoholism and cannot terminate it; 14. Patients with severe gastrointestinal ulcers or disease conditions that can affect drug absorption, distribution, metabolism, or excretion; 15. Those who participate in other intervention studies and receive exposure to experimental drugs or vaccines within 28 days; 16. During the screening period, any confirmed evidence showing abnormal laboratory indicators at level 4; 17. The following results were detected during the screening period: Alanine transaminase (ALT) = 5 times the upper limit of normal level (ULN) or Alanine transaminase (ALT) = 3 times ULN and total bilirubin = 1.5 times ULN; 18. The creatinine clearance rate calculated using CKD-EPI<30mL/min/1.73m2; 19. Within 28 days prior to screening, those who received the following treatment: -Radiotherapy -Cytotoxic chemotherapy drugs -Any systemic Immunosuppressive drug 20. Other researchers believe that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Cthrough; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virology inhibition rate;CD4+ T lymphocytes counts;PRO questionare;Drug resistance incidence rate; | — |
Countries
China
Contacts
Public ContactXiaoxin Xie
Guiyang public treatment center
Outcome results
None listed