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Clinical effect and safety of HIV patients with hypoviremia after receiving optimal treatment strategy

Clinical effect and safety of HIV patients with hypoviremia after receiving optimal treatment strategy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088231
Enrollment
Unknown
Registered
2024-08-14
Start date
2024-08-16
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

HIV/AIDS

Interventions

The traditional HIV hypoviremia management model group:According to the patients condition, researchers can choose their own dual or triple antiretroviral therapy without ABT until 24 weeks.
A new model group for optimized management of hypoviremia:ABT+ original ART scheme /OBR, until 24 weeks

Sponsors

Zhengzhou Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Over 18 years old (including the critical value), both Chinese male and female; 2) Diagnosed with HIV/AIDS and received antiviral treatment for more than 24 weeks;; 3) The last virological test before screening (within 6 months) was 50 copies /mL= plasma HIV-1 RNA < 1000 copies /mL, and the time before screening was at least 2 weeks from the screening retest date, and the virological test was maintained at 50 copies /mL= plasma HIV-1 RNA < 1000 copies/ml;. 4) Sign the informed consent of the patient voluntarily, and ensure the follow-up; 5) Unplanned relocation from the current test site during the course of the test.

Exclusion criteria

Exclusion criteria: 1) Use of Fusion inhibitors targeting gp41 within the previous 3 months; 2) Active opportunistic infection or AIDS-related malignancy (as stipulated in the national AIDS Treatment guidelines); Patients who had an opportunistic infection in the 6 months prior to enrollment, but whose disease was considered stable by investigators for less than 14 days; Any liver disease caused by vascular, metabolic, autoimmune or tumor; 3) Severe cardiovascular disease, cancer, acute severe infection, kidney injury, and other diseases that the researchers determined could not be included; 4) Known resistance to the investigational drug or allergy to the active ingredient or any additive of the investigational drug; 5) The following results were detected during the screening period: hemoglobin 1.5 times the upper limit of normal level, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >3 times the upper limit of normal level, and total bilirubin >2 times the upper limit of normal level; 6) Pregnant and lactating women; 7) Those who have family planning; 8) Gowster; 9) Patients with serious mental and neurological diseases; 10) Those who have a history of alcoholism and cannot stop; 11) severe gastrointestinal ulcer; 12) Acute hepatitis; Acute and chronic pancreatitis; 13) Situations in which other researchers consider it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
HIV-1 RNA;

Secondary

MeasureTime frame
CD4+T lymphocyte count;Life quality score;New incidence of AIDS-related diseases;CD8+T lymphocyte count;The ratio of CD4+/CD8+T;AIDS-related medical expenses;

Countries

China

Contacts

Public ContactXuan Yang

Zhengzhou Sixth People's Hospital

yangxuan2016@126.com+86 371 6033 1701

Outcome results

None listed

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