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NCT Number: NCT04667026

Observational Study on Patients With HIV/AIDS(OSPWH)

To establish a follow-up cohort of antiretroviral therapy(ART) for patients with HIV/AIDS, to observe the ART efficacy and adverse reactions, complications in the process of ART, as well as mortality and causes of death, so as to provide basis for further improving ART efficacy and quality of life of the patients.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases 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

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Linghua Li, MD, PhD

CONTACT

About this study

  • To establish a follow-up cohort of ART for HIV/AIDS patients: follow-up points: before treatment and 1, 2, 3 months after treatment, and every 3 months after treatment.
  • To observe the ART efficacy and adverse reactions: The clinical manifestations, laboratory and auxiliary examination indexes of each follow-up time point was observed in the follow-up cohort, including blood routine, liver function, renal function, blood lipid, blood glucose, urine routine, plasma HIV RNA,CD4 cell count, hepatitis index and syphilis index, etc. If HIV RNA is more than 1000 copies/ml, after treatment for more than 6 months, peripheral blood 10ml should be retained and drug resistance should be detected.
  • To investigate the complications of HIV/AIDS patients before and after ART.
  • To investigate the mortality and causes of death in patients with HIV/AIDS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients has a history of diagnosis of HIV.
  • Receiving antiretroviral therapy.
  • Good treatment compliance.

Exclusion criteria

  • Aged less than 14 years of old.

Treatment and study plan

Primary outcomes

  1. The rate of virological suppression after antiretroviral therapy.

    Time frame: Year 10

    After ART, HIV RNA level in plasma were quantified every year. The rate of HIV-RNA<400 copies/ml will be used to evaluate the efficacy of ART and the variation tendency of the rate of virological suppression will be described.

Secondary outcomes

  1. The CD4+T cell counts after ART.

    Time frame: Year 10

    The CD4+T cell count in plasma were detected every 3 months. The variation tendency of CD4+Tcell count will be described.

  2. All-cause mortality among HIV/AIDS after ART.

    Time frame: Year 10

    Describe the all-cause mortality among HIV/AIDS after ART and analyze the trend.

  3. The incidence of adverse reactions after ART.

    Time frame: Year 10

    In order to assess the adverse reactions after ART, the clinical symptoms were recorded, such as respiratory symptoms, digestive system symptoms, nervous system symptoms, and mental symptoms, etc. And cytological and biochemical indexes were detected such as blood routine, liver function, renal function, blood lipid, blood glucose, urine routine, etc. Calculate the incidence of adverse reactions after ART for 10 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Linghua Li, MD,PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Guangzhou 8th People's Hospital

Other

Registry information

Official study title

Observational Study of Antiretroviral Therapy Cohort in Patients With HIV/AIDS

Acronym: OSPWH

Important dates

Study start
2009
Primary completion
2030
Study completion
2031
First posted
Dec 14, 2020
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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