Prospective, non-inferior, randomized controlled trial of post-exposure prevention regimens for HIV

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900027321

Enrollment

Unknown

Registered

2019-11-08

Start date

2019-11-23

Completion date

Unknown

Last updated

2019-11-11

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

Conditions

AIDS

Interventions

The experimental group:Once a day with Elvitegravir150mg/Cobicistat 150mg/Emtricitabine200mg/Tenofovir AlafenamideFumarate 10mg Tablets

The control group:Lamiwudine300mg/Tenofovir Disoproxl1 Pumarnte Tablets 300mg once a day plus Dolutegravir Sodium Tablets 50mg once a day

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 60, weighing > 35kg, male and female; 2. Those who are clinically considered to be at high risk of HIV exposure should initiate post-exposure prophylaxis,the source of exposure may be confirmed hiv-positive or unknown HIV status; 3. Exposure must occur within 72 hours; 4. Negative HIV antibody test; 5. Personnel meeting the PEP initiation standard are willing to be treated once a day with eccoenotril tablets or lamivudine tenofovir tablets plus dotyravir sodium tablets for a course of 28 days; 6. Informed consent of research protocol has been signed.

Exclusion criteria

Exclusion criteria: 1. Creatinine clearance (CrCl) value <30mL/min; 2. Pregnant or lactating women; 3. Severe liver function impairment; 4. Also taking the following drugs: alpha 1-adrenergic receptor antagonist: afzosin; Antiarrhythmic drugs: amiodarone, quinidine;Anticonvulsants: carbamazepine, phenobarbital, phenytoin; Anti-mycobacterium drugs: rifampin; Ergot derivatives: dihydroergotamine, ergotine, ergotamine;Gastrointestinal motility enhancer: cisapride; Chinese herbal medicine: st. John's wort (Hypericumperforatum) hmgco-a reductase inhibitors: lovastatin, simvastatin; Antipsychotic drugs: ruprasidone, pimozyte;Pde-5 inhibitor: sildenafil for pulmonary hypertension; Sedatives/sleeping pills: orally administered midazolam, triazolam; 5. Inability or unwillingness to provide informed consent or comply with test requirements.

Design outcomes

Primary

Measure	Time frame
HIV antibody positive rate;	—

Secondary

Measure	Time frame
Routine blood test;Routine urine test;Liver function test;Renal function test;HBV serological detection;HCV antibody detection;Antibody detection of syphilis;	—

Countries

China

Contacts

Public ContactJinyu Xia

The fifth affiliated hospital of sun yat-sen university

Xiajinyu1960@126.com+86 13823078064

Outcome results

None listed

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