A Phase 1 interventional study of MTP-PE/MF59 and Env 2-3 in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59 adjuvant in adult volunteers with HIV infection.
By vaccinating those who have HIV infection, perhaps the replication (reproduction) of existing viral strains can be suppressed and the asymptomatic period early in the infectious process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4 responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.
By vaccinating those who have HIV infection, perhaps the replication (reproduction) of existing viral strains can be suppressed and the asymptomatic period early in the infectious process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4 responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.
Eight patients are entered in the pilot portion of the study, thirty patients are entered on Part A and fifteen patients are entered on Part B. In the pilot study, patients receive 30 mcg Env 2-3 vaccine plus 0 - 10 mcg MTP-PE/MF59 adjuvant. Patients on Part A receive one of the following: MF59 emulsion only; 100 mcg MTP-PE/MF59 only; 30 mcg Env 2-3 with MF59 emulsion only; or 30 mcg Env 2-3 vaccine with 100 mcg MTP-PE/MF59. Patients on Part B receive either 100 mcg MTP-PE/MF59 only or 30 mcg Env 2-3 vaccine plus 100 mcg MTP-PE/MF59. Treatment is administered on days 0, 28, and 112, and patients are followed for up to 10 months. Per amendment, patients may receive two additional doses of 30 mcg Env 2-3 or placebo in MTP-PE/MF59 at 7 and 10 months (Parts A and B) or 9 and 12 months (Pilot study) after their initial inoculation.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 8 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must be:
Prior Medication: Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Prior Medication:
Excluded:
Patients may not have the following prior conditions:
Use of illicit drugs or significant amounts of alcohol that, in the opinion of the principal investigator, would interfere with compliance with the study.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)