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A prospective, randomized, non-inferior clinical trial for antiviral therapy optimization programs for AIDS patients

A prospective, randomized, non-inferior clinical trial for antiviral therapy optimization programs for AIDS patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020750
Enrollment
Unknown
Registered
2019-01-16
Start date
2019-02-15
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

AIDS

Interventions

Reference treatment group:Zidovudine 300mg twice daily / tenofovir 300mg once daily + lamivudine 300mg once daily + nevirapine 200mg twice daily / efavirenz 600mg once daily
Optimized treatment group:Lopinavir/ritonavir 500mg twice daily + lamivudine 300mg once daily

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Asians aged 18 to 60 years old; 2. with HIV antibody positive for at least 3 months and hepatitis B surface antigen negative; 3. HIV-RNA detected in serum (PCR detection 200/µL; 5. All men and women of childbearing age must use effective contraception during the study period and within 3 months of the completion of treatment; 6. After 24 weeks of the national standard treatment regimen,HIV-RNA was < 50 copies/ml.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating woman; 2. Combined with active hepatitis; 3. Other chronic liver diseases; 4. Severe mental illness, suicide history or use of sedatives; 5. Immune-mediated disease or malignant disease, drug addiction within one year before joining the test, unable or unwilling to provide informed consent or compliance 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 Affilated Hosipital Of Sun Yat-sen University

Xiajinyu1960@126.com+86 13823078064

Outcome results

None listed

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