A Real-world Study of Lamivudine and Dotiravir Sodium Tablets in the Treatment-naïve HIV-1 Infected Patients

NCT05332470 | Unknown FDA Drug

• 1 other identifier: PekingUMCH record ZS-3419D
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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 initial treatment in HIV-naÏve patients. However there is no real- life data. The investigators' results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with DTG (dolutegravir) + 3TC(lamivudine ), to verify efficacy and tolerance in real life. The investigators' hypothesis is that the data will be similar to those reported in clinical trials.

Conditions

HIV-1-infection

Keywords

Lamivudine and Dotiravir Sodium Tablets; Dovato

Outcome Measures

Primary Outcomes (1)

• Proportion of individuals with HIV-1 RNA <50 copies/ml at 24 weeks

  Proportion of individuals with HIV-1 RNA \<50 copies/ml at 24 weeks

  24 weeks

Secondary Outcomes (1)

• Proportion of individuals with HIV-1 RNA <50 copies/ml at 48 weeks

  48 weeks

Interventions

Lamivudine and Dotiravir Sodium Tablets DRUG

3TC (300 mg p.o. q 24 h) plus DTG (50 mg p.o. q 24 h)

Also known as: Dovato

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the treatment-naïve HIV-1 infected patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Interventions

Lamivudine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• WEI Lyu

  Department of Infectious Diseases, PekingUMCH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

QING ZHANG

CONTACT

15001278131; zhangqingpumch@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 18, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: May 31, 2025
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share