Clinical trial NCT03603977: Simplified Treatment of Anti-retrovirus in China (C-STAR)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV/AIDS
Keywords: Simplified Therapy Regimen
Real World Study
HIV-1-infected patients
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
Collaborators: name: Guiyang Public Health Clinical Center
name: The Third People's Hospital of Kunming
name: The Second People's Hospital of Nanjing
name: Wuhan Union Hospital, China
name: The Third People's Hospital of Guilin
name: Guangxi Longtan hospital
name: The Fourth People's Hospital of Nanning
name: LiuZhou People's Hospital
name: Tianjin Second People's Hospital
name: The Sixth People's Hospital of Shenyang
name: The Sixth People's Hospital of Henan
name: The Sixth People's Hospital of Xinjiang
name: The Eighth People's Hospital of Xi'an
First posted: 2018-07-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The rate of virus inhibition
timeFrame: 36 Months
Secondary outcomes:
measure: The immunological ability
timeFrame: 36 Months
Other outcomes:
measure: The level of compliance
timeFrame: 36 Months
Locations:
city: Guangzhou
country: China
facility: Guangzhou 8th People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou 8th People's Hospital
name: Weiping Cai, Bachelor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.