AIDS
Conditions
Interventions
Group 1:ABT+DTG
Group 2:ABT+TDF+3TC
Group 3:DTG+TDF+3TC
Sponsors
Chongqing Public Health Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: HIV exposed subjects are required to meet all of the following criteria for enrollment into the study. 1. Males and females, aged >= 18 years; 2. History of HIV exposure: HIV exposure source damages skin (stabbing or cuts, etc.) or it is contaminated with incomplete skin or mucosa; or high-risk sexual behavior with HIV-infected or potential/suspected HIV-infected persons; 3. Receiving the first dose of blocking drug within 72 hours after exposure; 4. HIV antibody negative when exposed; 5. Both male and female subjects and their partners of childbearing potential must agree to contraception; 6. Females of childbearing potential must have a negative urine pregnancy test; 7. Willing and able to participate in all aspects of the study, including use of intravenous medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
Exclusion criteria
Exclusion criteria: 1) The exposure time exceeds 72h; 2) Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study; 3) Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg); 4) Any known allergy or antibodies to the study drug or excipients; 5) Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for 28 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AE) and serious adverse events (SAE);Compliance;HIV infection rate after exposure (Day 28);HIV infection rate after exposure (Week 12); | — |
Countries
China
Contacts
Public ContactYaokai Chen
Chongqing Public Health Medical Center
Outcome results
None listed