Draft Version 1.0 · April 2026 · Draft for Public Comment

This standard defines eligibility and protocol language requirements governing the participation of people living with HIV (PLHIV) in non-HIV clinical trials. It provides operational protocol language and structured decision logic enabling sponsors, protocol writers, and clinical operations teams to implement HIV inclusion based on clinical stability parameters and pharmacologic risk assessment rather than HIV diagnosis alone.

This standard operationalizes the eligibility principles in the DHHS HIV Treatment Guidelines and IAS-USA Guidelines for clinical research protocol design purposes, translating clinical management guidance into implementation-ready protocol language. It aligns with ICH E8(R1) and ICH E6(R3), and is companion to the SGMA Cardiovascular DDI Governance Framework (SGMA-GOV-HIV-CV-001).

Open for Comments until 30th October 2026

Document	HIV Inclusion Protocol Standard
Standard Code	SGMA-STD-HIV-001
Document Type	Clinical Research Standard
Version	Draft Version 1.0 (2026)
Publication Date	April 2026
Status	Draft for Public Comment
Publisher	SGMA (Scientific Governance and Measurement Authority)
License	Creative Commons Attribution 4.0 International (CC BY 4.0)
Standards Architecture	SGMA-ARC-001
Companion Framework	SGMA-GOV-HIV-CV-001 · Cardiovascular DDI Governance Framework
Companion Standard	SGMA-GOV-PP-001 · Publications and Presentations Authorship Standards
Related Standards	SGMA-ARC-001 · SGMA-STD-001 · SGMA-STD-002 · SGMA-GOV-HIV-CV-001 · SGMA-GOV-PP-001