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Clinical observation for the application of integrase inhibitor (DTG) regimen in patients with newly diagnosed AIDS complicated with opportunistic infection

Clinical observation for the application of integrase inhibitor (DTG) regimen in patients with newly diagnosed AIDS complicated with opportunistic infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025599
Enrollment
Unknown
Registered
2019-09-02
Start date
2019-10-08
Completion date
Unknown
Last updated
2019-09-02

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

Conditions

AIDS

Interventions

DTG Group:Use the ART program with DTG
non-DTG group:Use an ART solution that does not contain DTG

Sponsors

Zhengzhou Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Male and female aged 18-65 years; (2) HIV antibody confirmation test is positive; (3) Those who have not received anti-HIV treatment and have opportunistic infections; (4) HIV viral load >=1000 copies/mL; (5) Those who have no recent birth plans and who agree to take effective non-pharmaceutical contraceptives during the trial period and within 3 months after the end of dosing; (6) According to clinical judgment, the ART regimen containing the integrase inhibitor DTG or other ART regimen without integrase inhibitor can be used; (7) Subjects should fully understand the purpose, nature, methods, and possible adverse reactions, and voluntarily participate in the trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who have received anti-HIV treatment; (2) HIV RNA <500 copies/ml; (3) Pregnant women or women of childbearing age have a pregnancy plan; (4) patients with tumors; (5) Poor medication compliance (if it is not possible to take medication according to doctor's advice and can not return to follow the time node); (6) Patients with a mental illness or a previous history of mental illness; (7) suspect or determine the history of alcohol and drug abuse; (8) Those who have entered other clinical trials in the past 3 months; (9) Other factors that the investigator believes are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Lymphocyte subset;HIV-1 viral load;

Secondary

MeasureTime frame
IL-6;Blood routine;CRP;

Countries

China

Contacts

Public ContactZhao Qingxia

Zhengzhou Sixth People's Hospital

zhqx666@163.com+86 13623816821

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026