Simplified Treatment of Anti-retrovirus in China (C-STAR)
NCT ID: NCT03603977
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2017-11-01
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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).
Lpv/r+3TC
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.
Interventions
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Lpv/r+3TC
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Agree to use simplified therapy regimen.
3. Agree to detect CD4 count at least once per half a year
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Guiyang Public Health Clinical Center
UNKNOWN
The Third People's Hospital of Kunming
UNKNOWN
The Second People's Hospital of Nanjing
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
The Third People's Hospital of Guilin
UNKNOWN
Guangxi Longtan hospital
UNKNOWN
The Fourth People's Hospital of Nanning
OTHER
LiuZhou People's Hospital
OTHER
Tianjin Second People's Hospital
OTHER
The Sixth People's Hospital of Shenyang
OTHER
The Sixth People's Hospital of Henan
UNKNOWN
The Sixth People's Hospital of Xinjiang
UNKNOWN
The Eighth People's Hospital of Xi'an
UNKNOWN
Guangzhou 8th People's Hospital
OTHER
Responsible Party
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Linghua LI
Vice Chief physician
Principal Investigators
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Weiping Cai, Bachelor
Role: STUDY_CHAIR
Guangzhou 8th People's Hospital
Locations
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Guangzhou 8th People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Arribas 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.
Ciaffi 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.
Other Identifiers
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GZ8H-2017014
Identifier Type: -
Identifier Source: org_study_id
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