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Safety and Tolerability of AAV8 Delivery of a Broadly Neutralizing Antibody in Adults Living With HIV: a Phase 1, Dose-escalation Trial
Bu çalışma, HIV ile yaşayan yetişkinlerde AAV8 taşıyıcısı aracılığıyla geniş nötralize edici bir antikorun (VRC-HIVAAV070-00-GT / AAV8-VRC07) gen aktarımı yoluyla verilmesinin güvenliğini ve vücut tarafından ne kadar iyi tolere edildiğini incelemektedir. Çalışmaya, HIV-1 enfeksiyonu olan ve en az 3 aydır stabil antiretroviral tedavi alan 18-65 yaş arası yetişkinler katılabilmektedir. Çalışma Faz 1 aşamasında yürütülmektedir; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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:
1. White blood cell count (WBC) 2,500-12,000/mm\^3;
2. WBC differential either within institutional normal range or accompanied by approval of the Principal Investigator (PI) or designee;
3. Platelets = 125,000-400,000/mm\^3;
4. Hemoglobin greater than or equal to 10.0 gm/dL;
5. Creatinine less than or equal to 1.25 x upper limit of normal (ULN);
6. Alanine aminotransferase (ALT) less than or equal to 1.1 x ULN;
7. Aspartate aminotransferase (AST) less than or equal to 1.1 x ULN; and,
8. 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.