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A clinical research for Biktarvy following potential exposure to HIV-1

A clinical research for Biktarvy following potential exposure to HIV-1

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059994
Enrollment
Unknown
Registered
2022-05-14
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

HIV/AIDS

Interventions

experimental group:Biktarvy is taken orally once a day.
Control group:TDF+FTC+DTG/RAL

Sponsors

Guiyang public health treatment center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18, male or female; 2.HIV rapid test is negative; 3. Willing to sign a written informed consent form; 4. Willing and able to complete all research follow-ups; 5. Willing to participate in all research activities; 6. Fertility women: they are willing to take contraceptive measures during the period of taking the research drugs; 7. After HIV-1 sexual exposure, you can take the first dose of study drug within 72 hours.

Exclusion criteria

Exclusion criteria: 1. The known exposure source is HIV negative; 2. Known intolerance or allergy to drugs or excipients used in this study; 3. In the opinion of the researcher, there may be any potential violation of test compliance or any other situation that affects the evaluation of safety and effectiveness; 4.The exposure time exceeds 72h.

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 ContactHai Long

Guiyang public health treatment center

longlong1225@126.com+86 18685151613

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026