Basic Information


GTO ID GTC0404
Trial ID NCT03374202
Disease HIV Infection
Altered gene VRC07
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment VRC-HIVAAV070-00-GT
PhasePhase1
Recruitment statusActive, Not Recruiting
TitleVRC 603: A Phase I Dose-Escalation Study of the Safety of AAV8-VRC07 (VRC-HIVAAV070-00-GT) Recombinant AAV Vector Expressing VRC07 HIV-1 Neutralizing Antibody in Antiretroviral-Treated, HIV-1 Infected Adults With Controlled Viremia
Year2017
CountryUnited States
Company sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Other ID(s)180030|18-I-0030
Vector information
Vectoradeno-associated virus
ConstructAAV8-VRC07
Vector typeadeno-associated virus serotype 8 (AAV8) vector
Transgene/Inserted genethe VRC07 IgG heavy chain (VRC07 IgG HC) and the VRC07 IgG light chain (VRC07 LC) coding sequences
Regulatory elementa CASI promoter consisting of a cytomegalovirus (CMV) enhancer, a chicken β-actin promoter, a splice donor (SD) inserted between the β-actin promoter and a human ubiquitin C enhancer element, and a splice acceptor (SA); a truncated woodchuck hepatitis post-translational regulatory element (WPRE); a single SV40 poly-A sequence (SV40 polyA)

Clinical Result

Cohort1: dose level 1
Administration route intramuscular injection
Dosage 5E10 vg/kg
Pts 3
Age Adult, Older_Adult
Adverse reactions 2/3(Gastrointestinal disorders; Aspartate aminotransferase increased; Blood creatinine increased)
References PMID: 35411076
Cohort2: dose level 2
Administration route intramuscular injection
Dosage 5E11 vg/kg
Pts 3
Age Adult, Older_Adult
Adverse reactions 2/3(Infections and infestations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders)
References PMID: 35411076
Cohort3: dose level 3
Administration route intramuscular injection
Dosage 2.5E12 vg/kg
Pts 4
Age Adult, Older_Adult
Adverse reactions 4/4(General disorders; Blood creatinine increased; Musculoskeletal and connective tissue disorders; Nervous system disorders)
References PMID: 35411076

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