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

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ClinicalTrials.gov Identifier: NCT03603977
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

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
HIV/AIDS Drug: Lpv/r+3TC

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.

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Study Type : Observational
Estimated 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 : November 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort 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 Name: A simplified therapy regimen




Primary Outcome Measures :
  1. The rate of virus inhibition [ Time Frame: 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 [ Time Frame: 36 Months ]
    the count of CD4 cells


Other Outcome Measures:
  1. The level of compliance [ Time Frame: 36 Months ]
    To explicit the number of people who have completed the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603977


Contacts
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Contact: Linghua Li, Doctor 13725297174 llheliza@126.com
Contact: Weiping Cai, Bachelor 13808815909 gz8hcwp@126.com

Locations
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China, Guangdong
Guangzhou 8th People's Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linghua Li, Doctor    13725297174    llheliza@126.com   
Contact: Weiping Cai, Bachelor    13808815909    gz8hcwp@126.com   
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
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Study Chair: Weiping Cai, Bachelor Guangzhou 8th People's Hospital

Publications:

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Responsible Party: Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT03603977     History of Changes
Other Study ID Numbers: GZ8H-2017014
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:
Simplified Therapy Regimen
Real World Study
HIV-1-infected patients

Additional relevant MeSH terms:
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Ritonavir
Lopinavir
Lamivudine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors