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NCT Number: NCT03603977

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

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

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou 8th People's Hospital

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lpv/r+3TC

Drug

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

Primary outcomes

  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 outcomes

  1. The immunological ability

    Time frame: 36 Months

    the count of CD4 cells

Other outcomes

  1. The level of compliance

    Time frame: 36 Months

    To explicit the number of people who have completed the treatment

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Guangzhou 8th People's Hospital

Other

Collaborators

  • Guangxi Longtan hospital
  • Guiyang Public Health Clinical Center
  • LiuZhou People's Hospital
  • Shenyang Sixth 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 Xinjiang
  • The Third People's Hospital of Guilin
  • The Third People's Hospital of Kunming
  • Tianjin Second People's Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

A Simplified Therapy Regimen Study of Lopinavir and Ritonavir Combined With Lamivudine for HIV-1 Infected Patients in the Real World of China

Important dates

Study start
2017
Primary completion
2025
Study completion
2030
First posted
Jul 27, 2018
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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