Simplified Treatment of Anti-retrovirus in China (C-STAR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lpv/r+3TC.
- Who it may be relevant to
- Registry conditions: HIV/AIDS. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Simplified Therapy Regimen Study of Lopinavir and Ritonavir Combined With Lamivudine for HIV-1 Infected Patients in the Real World of China
Overview
To observe the efficacy and safety of simplified therapy regimen for treating with HIV-1 infected patients in Chinese real word.
Detailed 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.
Interventions
- Drug 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.
Primary outcome measures
- The rate of virus inhibition [Time frame: 36 Months]
Secondary outcome measures (1)
- The immunological ability [Time frame: 36 Months]
Eligibility criteria
Inclusion criteria
- HIV-1 infection confirmed
- Agree to use simplified therapy regimen.
- Agree to detect CD4 count at least once per half a year
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Guangzhou 8th People's Hospital — Guangzhou
Publications
- 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 r PMID 24783988
- 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 s PMID 26062880
- 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 PMID 28566227
Identifiers
NCT: NCT03603977 · GZ8H-2017014