Safety and Tolerability of Biktarvy Following Potential Exposure to HIV-1

A Phase IV Open-Label Evaluation of Safety and Tolerability of Biktarvy Following Potential Exposure to HIV-1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048080

Enrollment

Unknown

Registered

2021-06-30

Start date

2021-07-05

Completion date

Unknown

Last updated

2022-03-07

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

Conditions

HIV infection

Interventions

Case series:Taking Biktarvy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged over 18 at time of first visit; 2. HIV uninfected on the basis of a negative HIV Rapid Test; 3. Willing and able to provide written informed consent; 4. Willing and able to return to all study visits; 5. Willing to participate in all study procedures; 6. Biologic women of childbearing potential: Willing to use contraception for as long as they are on study medication plus 7 days after; 7. Possible sexual exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and/or Breastfeeding; 2. Acute or Chronic Hepatitis B infection, by history; 3. Creatinine Clearance at or below 30mL/min (Cockcroft-Gault equation, Actual Weight); 4. Known intolerance or allergy to tenofovir DF, emtricitabine, elvitegravir or cobicistat; 5. Currently taking or plans to take prohibited medication while enrolled in the study, including Propulsid (Cisapride), UroXatral (Alfuzosin), Dihydroergotamine, Ergotamine, Methylergonovine, St John's Wort (Hypericum perforatum), Altocor, Altoprev, Mevacor (Lovastatin), Zocor (Simvastatin), Orap (Pimozide), Rifadin, Rimactane (Rifampin), Viagra (Sildenafil when dosed as REVATIO), Halcion (Triazolam), Versed (Midazolam) (when administered orally), Antiretroviral medications used to treat or prevent HIV infection.

Design outcomes

Primary

Measure	Time frame
Safety;Tolerability;Acceptability;	—

Countries

China

Contacts

Public ContactSun Lijun

Beijing Youan Hospital, Capital Medical University

sunlijunkity@163.com+86 13701354452

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026