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

Guangzhou Medical University

Status: Enrolling

Conditions: HIV/AIDS

Treatments: Drug: Lpv/r+3TC

Study type: Observational

Funder types: Other

Identifiers

NCT03603977

GZ8H-2017014

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

Lpv/r+3TC

Description:

These cases were given simplified therapy regimen including lopinavir(200mg) and ritonavir(50mg)500 mg,oral,bid) combined with lamivudine (300 mg,oral,qd).

Treatment:

Drug: Lpv/r+3TC