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

NCT ID: NCT03603977

Last Updated: 2022-09-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2030-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV/AIDS

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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A simplified therapy regimen

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guiyang Public Health Clinical Center

UNKNOWN

Sponsor Role collaborator

The Third People's Hospital of Kunming

UNKNOWN

Sponsor Role collaborator

The Second People's Hospital of Nanjing

UNKNOWN

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

The Third People's Hospital of Guilin

UNKNOWN

Sponsor Role collaborator

Guangxi Longtan hospital

UNKNOWN

Sponsor Role collaborator

The Fourth People's Hospital of Nanning

OTHER

Sponsor Role collaborator

LiuZhou People's Hospital

OTHER

Sponsor Role collaborator

Tianjin Second People's Hospital

OTHER

Sponsor Role collaborator

The Sixth People's Hospital of Shenyang

OTHER

Sponsor Role collaborator

The Sixth People's Hospital of Henan

UNKNOWN

Sponsor Role collaborator

The Sixth People's Hospital of Xinjiang

UNKNOWN

Sponsor Role collaborator

The Eighth People's Hospital of Xi'an

UNKNOWN

Sponsor Role collaborator

Guangzhou 8th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Linghua LI

Vice Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Linghua Li, Doctor

Role: CONTACT

020-83710825

Weiping Cai, Bachelor

Role: CONTACT

020-83710816

Facility Contacts

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Linghua Li, Doctor

Role: primary

020-83710825

Weiping Cai, Bachelor

Role: backup

020-83710816

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.

Reference Type BACKGROUND
PMID: 24783988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26062880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28566227 (View on PubMed)

Other Identifiers

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GZ8H-2017014

Identifier Type: -

Identifier Source: org_study_id

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