Valganciclovir for cytomegalovirus viraemia in advanced HIV disease: a phase 2b randomized placebo-controlled trial of valganciclovir for cytomegalovirus viraemia in adults and adolescents with advanced HIV disease
Bibliographic record
Abstract
from two hospitals in Uganda and South Africa. Participants will be randomized 1 : 1 to either valganciclovir 900 mg orally or matched placebo for 28 days. Safety monitoring and CMV viral load testing will occur weekly until week 4, and thereafter at week 8 and at study termination at week 12. The primary endpoint is a composite of adverse events of special interest, re-hospitalization or death within 8 weeks. Secondary endpoints include median reduction in CMV viral load at day 28 and week 12, proportion with CMV below the limit of detection at weeks 2, 4, 8 and 12, mortality, grade ≥3 adverse events and serious adverse events, duration of hospitalization, tolerability, HIV treatment response, proportion with ganciclovir resistance and valganciclovir pharmacokinetics. Data from the NIRVANA phase 2 trial including valganciclovir pharmacokinetic data will be used to inform design of a multi-site phase 3 randomized controlled trial powered for survival to investigate whether valganciclovir reduces mortality among hospitalized adults with AHD-associated CMV viraemia.This article is part of the discussion meeting issue 'The indirect effects of cytomegalovirus infection: mechanisms and consequences'.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".