Status:
UNKNOWN
A Real-world Study of Lamivudine and Dotiravir Sodium Tablets in the Treatment-naïve HIV-1 Infected Patients
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Brief Summary
Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato(Dolutegravir/lamivudine) as an in...
Detailed Description
Since 1996, HAART(Highly Active Antiretroviral Therapy) based on 3DR(3-drug regimens ) in PLHIV(people living with HIV) has decreased mortality and today, PLHIV have a life expectancy close to that of...
Eligibility Criteria
Inclusion
- Understand and sign the written informed consent ;
- Over 18 years old;
- Western Blot test confirmed HIV positive, and did not take any antiretroviral therapy;
- HIV viral load ≥1000 copies/ml ;
- Uncomplicated hepatitis B virus infection: HBsAg (-) ;
- Estimated glomerular filtration rate (GFR) \> 30ml/min (calculated by CKD - EPI);
- No serious liver function damage (Child C ) ;
- Be able to carry out antiviral treatment and regular follow-up according to the plan.
Exclusion
- Previously used ART or used PreP or PEP ;
- Have a history of mental or nervous system diseases or suicidal tendencies;
- Severe cardiovascular and respiratory system diseases, liver and kidney function damage, coagulation dysfunction, thrombocytopenia, circulatory system diseases, etc.;
- There are indications of glucocorticoid application during application or follow-up period;
- Radiotherapy, chemotherapy, cell therapy or therapeutic vaccine, immunomodulatory therapy, etc. are required within 28 days before the start of the study or during the study period;
- Participate in other drug trials;
- Those who are pregnant, breastfeeding or planning to become pregnant within one year;
- Poor compliance, unable to follow up on schedule.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05332470
Start Date
May 1 2022
End Date
May 31 2025
Last Update
April 18 2022
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