This study is NOT currently recruiting participants.
To see if AAV8-VRC07 is safe. To study if it causes cells to produce the VRC07 antibody.
Adults ages 18-65 who are HIV infected but in general good health and have been taking the same HIV medicine for at least 3 months
Participants were screened in a different protocol.
Participants received the study product on day 1. It was injected one or more times in the upper arm or thigh using a needle. Participants weight was measured to calculate the dose.
Women may have had a pregnancy test.
For 7 days after getting the study product, participants checked their temperature with a thermometer. They noted any symptoms in an electronic or paper diary.
Participants will have study visits. At each one, they will have a physical exam and medical history. They will have blood drawn and may have saliva collected.
After 1 year in the study: a visit every 6 months for the next 4 years.
Total study participation is 5 years.
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:
a. White blood cell count (WBC) 2,500-12,000/mm^3;
b. WBC differential either within institutional normal range or accompanied by approval of the Principal Investigator (PI) or designee;
c. Platelets = 125,000 400,000/mm^3;
d. Hemoglobin greater than or equal to 10.0 gm/dL;
e. Creatinine less than or equal to 1.25 x upper limit of normal (ULN);
f. Alanine aminotransferase (ALT) less than or equal to 1.1 x ULN;
g. Aspartate aminotransferase (AST) less than or equal to 1.1 x ULN; and,
h. 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.