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The efficacy and safety of clinical trial of BX-I AIDS therapeutic apparatus for patients who are failure for the second-line treatment of AIDS

The efficacy and safety of clinical trial of BX-I AIDS therapeutic apparatus for patients who are failure for the second-line treatment of AIDS

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026987
Enrollment
Unknown
Registered
2019-10-28
Start date
2019-10-14
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS

Interventions

Clinical Trial Group:BX-I combined with second-line treatment
control group: second-line treatment

Sponsors

Chongqing Public Health Medical Treatment Help Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18(including 18) to age 65(including 65) years, both male and female; (2) According to the standard of Healthy Industry of People's Republic of China(WS293-2019)-The Diagnosis Criteria of AIDS and HIV Infection, people who have accepted national free second-line anti-virus drug treatment and the period of the treatment have been lasted for more than 6 months, and he or she agrees to continue to take the drugs during this trial period; (3) HIV Viral load=1000 copies/mL; (4) Estimated survival life span > 6 months; (5) Fully understand the purpose, nature, method and any possible reactions of this trial, and all people voluntarily joined this study with informed consents.

Exclusion criteria

Exclusion criteria: (1) AIDS Patients who are under acute infection period; or already have some kind of disease that related to AIDS ; opportunistic infection before chosen one month ago; unstable status around one week (Except for subjects who take the relevant drug for the purpose of preventing opportunistic infection); (2) Have participated in the HIV vaccine clinical trial within 6 months, participated in other drug trials in the past 3 months or received immunomodulators (except Chinese medicine), radiotherapy and chemotherapy in the past 3 months; (3) The following results were detected during screening: hemoglobin 4 times ULN, total bilirubin > 2 times ULN, creatinine > 1 times ULN; (4) Those that are allergy to drugs used in this trial or allergic constitution; (5) According to the DAIDS rating scale, anyone who has rating 3 or rating 4 symptoms; judged by the research doctor in combination with clinical conditions, are not suitable for enrolling patients; (6) Those with a history of mental illness or mental illness; (7) Type A and B hemophilia patients; (8) Suspect or identify of the history abuse of alcohol, drugs and medicine; (9) Those who are under pregnant, suckling period and plan to pregnant near one year; from sign on the informed consents to the trial finished, those who are failure to meet the researchers requirements to avoid pregnant during the whole period of trial; (10) Systolic pressure is less than 80 mm/Hg; (11) Those that have severe bleeding or bleeding tendency; (12) Severe cardiopulmonary insufficiency including arrhythmia or coronary heart disease; (13) According to researchers judgment, the lowest possibility to be chosen into the trial group (such as weak, poor adherence and etc.) .

Design outcomes

Primary

MeasureTime frame
HIV viral load;

Secondary

MeasureTime frame
CD4 count;

Countries

China

Contacts

Public ContactYaokai Chen

Chongqing Public Health Medical Treatment Help Center

yaokaichen@hotmail.com+86 13638352995

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026