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Clinical evaluation of the simplified regimen for post-exposure prophylaxis of HIV

Clinical evaluation of the simplified regimen for post-exposure prophylaxis of HIV

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046125
Enrollment
Unknown
Registered
2021-05-04
Start date
2021-05-10
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

HIV

Interventions

experimental group:ABT 320mg ivgtt (Day 1 and Day 15))+DTG 50mg po qd
control group:TDF 300mg po qd / 3TC 300mg po qd or TDF 300mg po qd/FTC 200mg po qd+DTG 50mg po qd

Sponsors

Public Health Clinical Center of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Male aged over 18 years; 2.HIV exposure: having male or male homosexual sex and meeting the requirements of exposure risk assessment stipulated in technical Guidelines for Post-EXPOSURE Prevention of HIV (Trial) issued by The Center for STD/AIDS Prevention and Control, Chinese Center for Disease Control and Prevention; 3.Self-exposure occurred within 72 hours of the first dose; 4.With negative HIV antibody test at the initiation of treatment; 5.Provide signed informed consent and be able to cooperate with and participate in all aspects of the study, including the use of iv drugs, completion of all evaluations, visits to designated study centers, and compliance with all protocol requirements.

Exclusion criteria

Exclusion criteria: 1.Known exposure source person is HIV negative; 2.Known intolerance or allergy to the drugs or excipients used in this study; 3.Upon the investigator's determination, the subject may have any potential circumstance negatively impacting on treatment adherence, safety and effecacy evaluation.

Design outcomes

Primary

MeasureTime frame
Percentage of subjects who completed 28 days of prophylactic medication;

Secondary

MeasureTime frame
The incidence of adverse events (AE) and serious adverse events (SAE) ;Adherence to the regimen;HIV sero-conversion at 28 days and 12 weeks after exposure;

Countries

China

Contacts

Public ContactHe Shenghua

Public Health Clinical Center of Chengdu

13198552429@163.com+86 13198552429

Outcome results

None listed

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