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

Recruiting

• Conditions: HIV/AIDS
• Interventions: Drug: Lpv/r+3TC

• Registration Number: NCT03603977
• Lead Sponsor: Guangzhou 8th People's Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14
• Primary Completion: 2025-12-31
• Study Completion: 2030-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lpv/r+3TC	Lpv/r+3TC	These cases were given simplified therapy regimen including lopinavir(200mg) and ritonavir(50mg)500 mg,oral,bid) combined with lamivudine (300 mg,oral,qd).

Primary Outcome Measures

Name	Time	Method
The rate of virus inhibition	36 Months	the ratio of HIV RNA\< 50 copies/mL at 12, 24 or 36 months after treatment.

Secondary Outcome Measures

Name	Time	Method
The immunological ability	36 Months	the count of CD4 cells

Trial Locations

Locations (1)

Guangzhou 8th People's Hospital; 🇨🇳 Guangzhou, Guangdong, China