HIV
Conditions
Interventions
Case series:CCR5 gene editing
Sponsors
South University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
22 Years to 38 Years
Inclusion criteria
Inclusion criteria: 1. Married couple living in the People's Republic of China with HIV seropositivity (female negative, male positive); 2. Men and women 22–38 years old; 3. Males are clinically stable, failing to detect viral load of 250; at least in the past 12 months with a history of continuous antiretroviral therapy; 4. Clinically confirmed to meet the medical guidelines for IVF therapy; 5. Fully informed consent of the couple to understand the purpose, risks and benefits of the trial; 6. Both subjects are willing to commit to using preventive contraception or maintaining abstinence for at least two months before egg collection and within one month after birth.
Exclusion criteria
Exclusion criteria: 1. The viral load of the father before sperm collection is > 75 copies / mL; 2. Mother or father has genetic variation within the target sequence of the CRISPR/Cas9 gene editing; 3. Mother or father has genetic variation, creating a novel, high-probability off-target site for CCR5-targeted gene editing; 4. During the study, natural pregnancy or fertilization failed after two oocyte stimulation cycles; 5. Previously multiple in vitro fertilization (IVF) attempts failed; 6. Contraindications to use drugs during pregnancy; 7. With endocrine-related diseases, sexual hormones are at abnormal levels; 8. Currently using chemoradiotherapy drugs to treat tumor-related diseases; 9. Participated in or recently participated in another clinical trial using a research diagnostic test, drug or device; 10. Subjects with other diseases, including alcohol abuse or mental illness, that may influence the current protocol based on the researcher or clinician's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy and guarantee one or more live births;Father, mother and progeny genome-wide deep sequencing analysis; | — |
Countries
China
Contacts
Public ContactHe Jiankui
Southern University of Science and Technology
Outcome results
None listed