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Monitoring of Antiviral Therapy Indicators and Optimizing Treatment Management Model

Monitoring of Antiviral Therapy Indicators and Optimizing Treatment Management Model

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006528
Enrollment
Unknown
Registered
2015-05-31
Start date
2014-09-30
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

AIDS

Interventions

A:HIV-RNA viral load test (quantitative), immunology, blood routine and hepatorenal function test (quantitative) will be performed 0, 3, 6 and 12 months after treatment initiation respectively. Nation
B:HIV-RNA viral load test (quantitative), immunology, blood routine, and liver and hepatorenal function test (quantitative) will be performed 0, 3, 6 and 12 months after treatment initiation respectiv
C:According to current national guideline, HIV-RNA viral load test (quantitative) will be perfomed once a year
immunology, blood routine and hepatorenal function test (quantitative) will be performed 2-4 times each year. National first-line regimen will be applied: AZT/TDF+3TC+EFV/NVP.

Sponsors

8th People's Hospital of Guangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Subjects: 250 HIV treatment-naive patients who are above 18 years old with CD4+>200 /uL will be enrolled and assigned to different groups.

Exclusion criteria

Exclusion criteria: not available

Design outcomes

Primary

MeasureTime frame
The proportion of patients with HIV-1 RNA< 50 copies/ml in ITT population analysis at Week 48;HIV-1 RNA< 400 copies/ml in ITT population analysis at Week 24; safety, the proportion of patients without alteration of initial regimen and the drug resistance analysis results of treatment failure cases at Week 24 and Week 48; immunological response at Week 24 and Week 48.;

Countries

China

Contacts

Public ContactWeiping Cai
caiwp@163.net+86 13808815909

Outcome results

None listed

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