OA04-05. Safety and viral load changes in HIV-1 infected subjects treated with autologous dendritic immune therapy following ART discontinuation (CTN#239)
Bibliographic record
Abstract
We demonstrated in a phase 1 trial that an immunotherapy (AGS-004) consisting of a monocyte-derived dendritic cells (DC) and RNA encoding autologous HIV antigens (Gag, Nef, Rev, Vpr) derived from the patient's own pre-ART plasma induced immunogenicity in most patients. Based on these results a multicenter phase 2 trial was implemented to assess the safety and proportion of patients demonstrating viral load (VL) < 1000, < 5000 and < 10,000 copies/ml during the 12 week ART structured treatment interruption (STI). Subjects on their initial ART regimen with VL < 50 copies/ml, CD4 > 450 cells/μl, CD4 nadir > 200 cells/μl and a pre-ART VL > 10,000 to 500,000 copies/ml were eligible. The treatment consists of 4 intradermal AGS-004 doses administered monthly in combination with ART followed by two more doses during the 12 week STI. Subjects who participated in the phase 1 study were included and received a second cycle of AGS-004. Subjects may continue AGS-004 booster administration if VL remains < 10,000 copies/ml. 33 subjects were enrolled from 11 Canadian sites, and AGS-004 successfully manufactured and administered to 21 subjects. 9 subjects have successfully completed 12 weeks of STI. The immunotherapy related AEs were Grade 1 or 2 flu-like, GI symptoms, fatigue, and injection site reactions. During the STI, no reports of autoimmunity or AIDS defining events were observed. After an initial viral rebound, 4 out of 9 subjects had > 2 instances of VL measures < 1000 copies/mL when assessed every 2 weeks during the STI. At week 12 of STI 5 subjects had viral loads < 10,000 copies/ml with CD4 > 350 cells/μl including 4 subjects with viral loads < 5000 copies/ml. Results from this phase 2 autologous immunotherapy trial demonstrated that this therapy is safe and induced partial control of VL when compared to pre-ART VL during the 12-week STI.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".