HIV Inclusion Protocol Standard
*This is a draft document and is not for implementation. Submit comments using the email id
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 31st August 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 |
Cite This Document
SGMA. HIV Inclusion Protocol Standard. SGMA-STD-HIV-001. Draft Version 1.0, 2026. sgmastandards.org/hiv-inclusion-protocol-standard
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