Simplified Treatment of Anti-retrovirus in China (C-STAR)
A Simplified Therapy Regimen Study of Lopinavir and Ritonavir Combined With Lamivudine for HIV-1 Infected Patients in the Real World of China
1 other identifier
observational
600
1 country
1
Brief Summary
To observe the efficacy and safety of simplified therapy regimen for treating with HIV-1 infected patients in Chinese real word.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2030
ExpectedSeptember 14, 2022
September 1, 2022
8.2 years
July 19, 2018
September 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of virus inhibition
the ratio of HIV RNA\< 50 copies/mL at 12, 24 or 36 months after treatment.
36 Months
Secondary Outcomes (1)
The immunological ability
36 Months
Other Outcomes (1)
The level of compliance
36 Months
Study Arms (1)
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).
Interventions
It is a simplified therapy regimen study of lopinavir and ritonavir combined with lamivudine for HIV-1 infected patients in the real world of China.
Eligibility Criteria
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.
You may qualify if:
- HIV-1 infection confirmed
- Agree to use simplified therapy regimen.
- Agree to detect CD4 count at least once per half a year
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Guangzhou 8th People's Hospitallead
- Guiyang Public Health Clinical Centercollaborator
- The Third People's Hospital of Kunmingcollaborator
- The Second People's Hospital of Nanjingcollaborator
- The Third People's Hospital of Guilincollaborator
- Guangxi Longtan hospitalcollaborator
- The Fourth People's Hospital of Nanningcollaborator
- LiuZhou People's Hospitalcollaborator
- Tianjin Second People's Hospitalcollaborator
- The Sixth People's Hospital of Shenyangcollaborator
- The Sixth People's Hospital of Henancollaborator
- The Sixth People's Hospital of Xinjiangcollaborator
- The Eighth People's Hospital of Xi'ancollaborator
Study Sites (1)
Guangzhou 8th People's Hospital
Guangzhou, Guangdong, 510060, China
Related Publications (3)
Cahn P, Andrade-Villanueva J, Arribas JR, Gatell JM, Lama JR, Norton M, Patterson P, Sierra Madero J, Sued O, Figueroa MI, Rolon MJ; GARDEL Study Group. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis. 2014 Jul;14(7):572-80. doi: 10.1016/S1473-3099(14)70736-4. Epub 2014 Apr 27.
PMID: 24783988BACKGROUNDArribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martinez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabie A, Weiss L, Gatell JM; OLE/RIS-EST13 Study Group. Dual treatment with lopinavir-ritonavir plus lamivudine versus triple treatment with lopinavir-ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):785-92. doi: 10.1016/S1473-3099(15)00096-1. Epub 2015 Jun 7. Erratum In: Lancet Infect Dis. 2015 Aug;15(8):875. doi: 10.1016/S1473-3099(15)00112-7.
PMID: 26062880BACKGROUNDCiaffi L, Koulla-Shiro S, Sawadogo AB, Ndour CT, Eymard-Duvernay S, Mbouyap PR, Ayangma L, Zoungrana J, Gueye NFN, Diallo M, Izard S, Bado G, Kane CT, Aghokeng AF, Peeters M, Girard PM, Le Moing V, Reynes J, Delaporte E; MOBIDIP study group. Boosted protease inhibitor monotherapy versus boosted protease inhibitor plus lamivudine dual therapy as second-line maintenance treatment for HIV-1-infected patients in sub-Saharan Africa (ANRS12 286/MOBIDIP): a multicentre, randomised, parallel, open-label, superiority trial. Lancet HIV. 2017 Sep;4(9):e384-e392. doi: 10.1016/S2352-3018(17)30069-3. Epub 2017 May 28.
PMID: 28566227BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weiping Cai, Bachelor
Guangzhou 8th People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chief physician
Study Record Dates
First Submitted
July 19, 2018
First Posted
July 27, 2018
Study Start
November 1, 2017
Primary Completion
December 31, 2025
Study Completion (Estimated)
October 31, 2030
Last Updated
September 14, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share