Status:
ACTIVE_NOT_RECRUITING
Safety and Tolerability of AAV8 Delivery of a Broadly Neutralizing Antibody in Adults Living With HIV: a Phase 1, Dose-escalation Trial
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV-1 Infected Adults With Controlled Viremia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Background: The Human Immunodeficiency Virus (HIV) attacks the immune system. Scientists have created a gene that could be transferred to the cells of people with HIV. The gene should tell the cells ...
Detailed Description
Design: This is a Phase I study of the safety and tolerability of AAV8-VRC07 (VRC-HIVAAV070-00-GT) expressing VRC07 human monoclonal antibody with broad HIV-1 neutralizing activity in HIV-1 infected a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A volunteer must have met all of the following criteria:
- Able and willing to complete the informed consent process.
- 18 to 65 years of age.
- HIV-1 infected.
- On a stable antiretroviral regimen for greater than or equal to 3 months.
- Available for clinical follow-up through the last study visit.
- Based on history and examination, must be in general good health with no evidence of clinically significant lab abnormalities and without additional clinically significant medical conditions as per exclusion criteria.
- Willing to maintain or establish a relationship with a primary health care provider for medical management of HIV infection while participating in the study.
- Willing to have blood samples collected, stored indefinitely, and used for research purposes.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Laboratory tests assessing individual's health will be conducted within 84 days prior to enrollment and values must meet the following criteria:
- White blood cell count (WBC) 2,500-12,000/mm\^3;
- WBC differential either within institutional normal range or accompanied by approval of the Principal Investigator (PI) or designee;
- Platelets = 125,000-400,000/mm\^3;
- Hemoglobin greater than or equal to 10.0 gm/dL;
- Creatinine less than or equal to 1.25 x upper limit of normal (ULN);
- Alanine aminotransferase (ALT) less than or equal to 1.1 x ULN;
- Aspartate aminotransferase (AST) less than or equal to 1.1 x ULN; and,
- Viral Load (VL) less than or equal to 50 copies/mL and a CD4 count greater than or equal to 300/mcL (microliter).
- Male-Specific Criteria:
- Males must agree to use condoms for all sexual activity of any reproductive potential for 52 weeks after receiving the study product.
- Female-Specific Criteria:
- If a woman is sexually active with a male partner and has no history of hysterectomy, tubal ligation or menopause, she must agree to use either a prescription birth control method or a barrier birth control method from the time of study enrollment through study Week 52, or to be monogamous with a partner who has had a vasectomy.
- Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
- EXCLUSION CRITERIA:
- A volunteer would have been excluded if one or more of the following conditions applied:
- Previous receipt of monoclonal antibody whether licensed or investigational.
- Previous receipt of gene therapy product.
- Ongoing AIDS-related opportunistic infection (including oral thrush).
- Active injection drug use or active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- A titer of pre-existing antibodies to AAV8 capsid is greater than 1:90.
- Weight \> 115 kg for Group 3 participants only.
- History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence.
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- Active liver disease such as chronic hepatitis.
- Hypertension that is not well controlled by medication.
- Woman who is breast-feeding or planning to become pregnant during the study participation.
- Receipt of any investigational study agent within 28 days prior to enrollment.
- Current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including, but not limited to: diabetes mellitus type I; OR clinically significant forms of asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.
Exclusion
Key Trial Info
Start Date :
January 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03374202
Start Date
January 11 2018
End Date
August 8 2026
Last Update
April 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892