Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study.

Name: Αlpha¹ Rigor Record — Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study.
Item: Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study.
Rating: 100
Author: Αlpha¹

Ramgopal MN, Lalezari JP, Pires Dos Santos AG, Krishnan P, Vaidya TR, Zhou F, Betman H, Dorr P, Mostafa NM, Alcaide ML, Felizarta F, Routy JP

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Αlpha¹ Rigor Review — 3.5★ (Adequate), 0 critical, 2 high issues for “Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 15, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Problems surfaced4 types

Numerical inconsistencies1

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Overstated conclusions3

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

This Αlpha¹ Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and transparently reported phase 1b randomized controlled trial of budigalimab in people living with HIV-1. The manuscript demonstrates strong scientific premise, rigorous design, and comprehensive reporting across all eight rigor dimensions, with only minor copyedit-level inconsistencies and a few optional reporting enhancements.

This is an interventional study (randomized controlled trial). Both reviewers agreed on the study type. The evaluation covered all eight dimensions; several sub-criteria were marked not applicable due to the human clinical trial context (e.g., cell line authentication, housing conditions, IACUC). The statistics verification covered only 1 test (limited coverage), and the citation check found no integrity issues. The copyedit pass flagged minor consistency issues in the abstract and results.

7 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions8 pass

The introduction cites extensive prior research on PD-1 in HIV and SIV models, and the rationale for using budigalimab is logically linked to the study objectives. Limitations of prior research are acknowledged, such as the need for lower doses to improve tolerability.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes the scientific rationale for PD-1 blockade in HIV and builds on prior work.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“PD-1 blockade in non-human primates infected with simian immunodeficiency virus has resulted in multiple effects, including enhancement of HIV-specific CD8+ T cell proliferative potential...”

direct quote[Introduction, paragraph 4]

“The doses chosen for study in HIV treatment were derived from modeling using data from first-in-human studies of budigalimab and pharmacokinetic studies of another anti-PD-1 antibody with target-mediated drug disposition and were substantially lower and of shorter exposure duration than those used in oncology.”