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Evaluation of a prospective, non-interventional, multicenter, non-inferiority, real-world study comparing the efficacy of a daily oral antiretroviral regimen with a long-acting cetuximab-riptyline regimen in virologically suppressed HIV-1–infected adults

Evaluation of a prospective, non-interventional, multicenter, non-inferiority, real-world study comparing the efficacy of a daily oral antiretroviral regimen with a long-acting cetuximab-riptyline regimen in virologically suppressed HIV-1–infected adults

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119550
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

HIV

Interventions

LA group:NA
SOC group:NA

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years at the time of signing the informed consent form 2. Presence of proven HIV-1 infection 3. prior to study participation and irrespective of study participation status, initiating CAB+RPVLA therapy or continuing daily oral ART therapy, as indicated. Participants may be enrolled in the following treatment groups: (1) LA group: start CAB+RPV LA therapy according to indication (start injections directly and receive first injection at the study centre on the last day of any other antiretroviral therapy); (2) Control group: continue to receive the current standard oral antiretroviral regimen (first-line oral regimen in accordance with the recommendations of the Chinese HIV/AIDS Clinical Guidelines [2024 Edition]) and be stable on treatment for >= 3 months and virologically suppressed (HIV RNA = 6 months. 4. Understand and cooperate in completing the questionnaire 5. Sign the informed consent form for participation in the study.

Exclusion criteria

Exclusion criteria: 1. LA group: any contraindication to CAB LA, RPV LA (known resistance and/or hypersensitivity to CAB or RPV; loss of virological response due to co-administration of drugs that may significantly reduce CAB and/or RPV plasma concentrations); control group: contraindications to current use of conventional oral ART medications (e.g., drug allergy, drug resistance, severe hepatic or renal insufficiency, etc.). Control group: contraindications to the current use of conventional oral ART drugs (e.g. drug allergy, drug resistance, severe hepatic or renal insufficiency, inability to tolerate oral drugs) 2. LA group: history of CAB+RPV LA treatment before enrolment; control group: oral ART regimen has been adjusted within 3 months before enrolment or is planned to be adjusted within 3 months after enrolment. 3. Currently participating in any pharmacological or non-pharmacological interventional study.

Design outcomes

Primary

MeasureTime frame
HIV viral load;

Secondary

MeasureTime frame
CD4 cell;

Countries

China

Contacts

Public ContactLijun Sun

Beijing Youan Hospital, Capital Medical University

sunlijunkity@sina.com+86 10 8399 7431

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026