Simplified Treatment of Anti-retrovirus in China (C-STAR)
ConditionHIV/AIDS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuangzhou 8th People's Hospital
About this trial
To observe the efficacy and safety of simplified therapy regimen for treating with HIV-1 infected patients in Chinese real word.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HIV-1 infection confirmed
Agree to use simplified therapy regimen.
Agree to detect CD4 count at least once per half a year
Disqualifiers
Have participated in HIV vaccine clinical trial or other drug trials in the past three months.
Patients who could not complete the scheduled follow-up (such as weakness and poor compliance).
Patients who have the history of resistance or allergy to LPV/r or 3TC.
Trial population
Patients who are prescribed to take the simplified therapy regimen (LPV/r+ 3TC) because they are unable to tolerate the side-effect of or are not fit for the first-line free regimen in China, for example renal failure or osteoporosis, according to clinical judgment, no matter of the HIV-RNA viral loads and CD4 cell counts.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Lpv/r+3TC
DrugIt is a simplified therapy regimen study of lopinavir and ritonavir combined with lamivudine for HIV-1 infected patients in the real world of China.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Lpv/r+3TC1 intervention
Trial outcomes
Primary outcomes
1
The rate of virus inhibition
the ratio of HIV RNA\< 50 copies/mL at 12, 24 or 36 months after treatment.
Time frame
36 MonthsSecondary outcomes
1
The immunological ability
the count of CD4 cells
Time frame
36 MonthsOther outcomes
1
The level of compliance
To explicit the number of people who have completed the treatment
Time frame
36 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangzhou 8th People's Hospital
Lead sponsor
Guiyang Public Health Clinical Center
Collaborator
The Third People's Hospital of Kunming
Collaborator
The Second People's Hospital of Nanjing
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The Third People's Hospital of Guilin
Collaborator
Guangxi Longtan hospital
Collaborator
The Fourth People's Hospital of Nanning
Collaborator
LiuZhou People's Hospital
Collaborator
Tianjin Second People's Hospital
Collaborator
Shenyang Sixth People's Hospital
Collaborator
The Sixth People's Hospital of Henan
Collaborator
The Sixth People's Hospital of Xinjiang
Collaborator
The Eighth People's Hospital of Xi'an
Collaborator
Source ClinicalTrials.gov