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

Sponsor
Guangzhou 8th People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03603977
Collaborator
Guiyang Public Health Clinical Center (Other), The Third People's Hospital of Kunming (Other), The Second People's Hospital of Nanjing (Other), Wuhan Union Hospital, China (Other), The Third People's Hospital of Guilin (Other), Guangxi Longtan hospital (Other), 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 (Other), The Sixth People's Hospital of Xinjiang (Other), The Eighth People's Hospital of Xi'an (Other)
600
Enrollment
1
Location
60
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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).

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.
Other Names:
  • A simplified therapy regimen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The rate of virus inhibition [36 Months]

      the ratio of HIV RNA< 50 copies/mL at 12, 24 or 36 months after treatment.

    Secondary Outcome Measures

    1. The immunological ability [36 Months]

      the count of CD4 cells

    Other Outcome Measures

    1. The level of compliance [36 Months]

      To explicit the number of people who have completed the treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou 8th People's Hospital Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Guangzhou 8th People's Hospital
    • Guiyang Public Health Clinical Center
    • The Third People's Hospital of Kunming
    • The Second People's Hospital of Nanjing
    • Wuhan Union Hospital, China
    • The Third People's Hospital of Guilin
    • Guangxi Longtan hospital
    • The Fourth People's Hospital of Nanning
    • LiuZhou People's Hospital
    • Tianjin Second People's Hospital
    • The Sixth People's Hospital of Shenyang
    • The Sixth People's Hospital of Henan
    • The Sixth People's Hospital of Xinjiang
    • The Eighth People's Hospital of Xi'an

    Investigators

    • Study Chair: Weiping Cai, Bachelor, Guangzhou 8th People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03603977
    Other Study ID Numbers:
    • GZ8H-2017014
    First Posted:
    Jul 27, 2018
    Last Update Posted:
    Jul 20, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
    Simplified Therapy Regimen
    Real World Study
    HIV-1-infected patients
    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections

    Study Results

    No Results Posted as of Jul 20, 2021