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Simplified Treatment of Anti-retrovirus in China (C-STAR)

Simplified Treatment of Anti-retrovirus in China (C-STAR)

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

To observe the efficacy and safety of simplified therapy regimen for treating with HIV-1 infected patients in Chinese real word.

Description

This is an phase IV open-label, multicenter, single-arm clinical trial in. A total of 600 cases were planned to be recruited. These cases were given simplified therapy regimen of lopinavir (200mg) and ritonavir (50mg) (500mg, oral, bid ) combined with lamivudine (300mg, oral, qd. The observation duration is thirty-sixth months. Patients will be followed up before and 12, 24 and 36 months after receiving the simplified regimen, observing the viral inhibition rate and the change of CD4 cell count, the safety and patients'compliance.

Eligibility

Inclusion Criteria:

  1. HIV-1 infection confirmed
  2. Agree to use simplified therapy regimen.
  3. Agree to detect CD4 count at least once per half a year

Exclusion Criteria:

  1. Have participated in HIV vaccine clinical trial or other drug trials in the past three months.
  2. Patients who could not complete the scheduled follow-up (such as weakness and poor compliance).
  3. Patients who have the history of resistance or allergy to LPV/r or 3TC.

Study details
    HIV/AIDS

NCT03603977

Guangzhou 8th People's Hospital

25 January 2024

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