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

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03603977
• Other study ID #: GZ8H-2017014
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: October 31, 2030

Study information

• Verified date: September 2022
• Source: Guangzhou 8th People's Hospital
• Contact: Linghua Li, Doctor
• Phone: 020-83710825
• Email: llheliza[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
China	Guangzhou 8th People's Hospital	Guangzhou	Guangdong

Sponsors (14)

Lead Sponsor

Collaborator

Guangzhou 8th People's Hospital

Guangxi Longtan hospital, Guiyang Public Health Clinical Center, LiuZhou People's Hospital, The Eighth People's Hospital of Xi'an, The Fourth People's Hospital of Nanning, The Second People's Hospital of Nanjing, The Sixth People's Hospital of Henan, The Sixth People's Hospital of Shenyang, The Sixth People's Hospital of Xinjiang, The Third People's Hospital of Guilin, The Third People's Hospital of Kunming, Tianjin Second People's Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Arribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martínez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabié 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The level of compliance	To explicit the number of people who have completed the treatment	36 Months
Primary	The rate of virus inhibition	the ratio of HIV RNA< 50 copies/mL at 12, 24 or 36 months after treatment.	36 Months
Secondary	The immunological ability	the count of CD4 cells	36 Months