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A real world study for a simplified regimen of dolutegravir combined with lamivudine in the treatment of newly infected HIV patients

A real world study for a simplified regimen of dolutegravir combined with lamivudine in the treatment of newly infected HIV patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027640
Enrollment
Unknown
Registered
2019-11-22
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

HIV/AIDS

Interventions

Case series:DTG 50mg +3TC 300mg once a day

Sponsors

The Fifth Affiliated Hosipital Of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old, male or female; 2. Confirmed HIV-1 infection; 3. judgment, for any reason. For example, (but not limited to) patients who cannot tolerate the national first-line treatment regimen and cannot use the national standard three-drug treatment regimen due to renal insufficiency or osteoporosis; 4. HIV-RNA iral load and CD4 cell count were not limited; 5. CD4 can be detected at least 3 times in the first year (including baseline and 24 weeks of treatment).CD4 should be tested at least once every six months; 6. informed consent for treatment has been signed.

Exclusion criteria

Exclusion criteria: 1. participated in clinical trials of HIV vaccine or other drug trials within the past three months; 2. evidence of drug addiction (including excessive alcohol intake) in the year prior to the trial; 3. a clear history of DTG or 3TC allergy; 4. hepatitis B surface antigen (HBsAg) and/or HBV-DNA positive; 5. pregnant or lactating women; 6. other history or evidence of chronic liver disease (e.g. hemochromia, autoimmune hepatitis, alcoholic liver disease, toxic exposure, thalassemia); 7. a history of serious mental illness, especially depression.A serious mental illness is one that has been on antidepressants or used to treat depression or mental illness for at least three months at any time in the past; 8. therapeutic doses of sedatives, or any history of suicide attempts, hospitalization for mental illness, incapacity to work for a period of time due to mental illness; 9. a history of severe epilepsy or currently being treated with sedatives; 10. immune-mediated disease, or evidence of other severe or malignant diseases, or other conditions of the patient that make the investigator consider him/her unsuitable to participate in this study; 11. the researcher judged that the patients could not complete the scheduled follow-up; 12. inability or unwillingness to provide informed consent or comply with test requirements.

Design outcomes

Primary

MeasureTime frame
Virological breakthrough rate (HIV RNA <400 copies/mL);CD4+T lymphocyte count;

Countries

China

Contacts

Public ContactJinyu Xia

The Fifth Affiliated Hosipital Of Sun Yat-sen University

lisideng@foxmail.com+86 13823078064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026