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Clinical Performance Study for Use of the PhenoSense® HIV Monoclonal Antibody (mAb) Assay in Gilead Sciences Phase 3 Clinical Evaluation of Switching to Teropavimab and Zinlirvimab in Combination with Lenacapavir Twice-Yearly or Continuing on an Oral Stable Baseline Regimen in Virologically Suppressed Adults With HIV-1 Infection - PJ04190_Clinical Performance Study for Use of the PhenoSense® HIV Monoclonal Antibody (mAb) Assay in Gilead Sciences Phase 3 Clinical Evaluation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON61389

Enrollment

Registered

2026-03-18

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, AIDS, virologically suppressed people HIV/ AIDS

Interventions

The PhenoSense® HIV Monoclonal Antibody (mAb) Assay&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Specimens must be human peripheral blood mononuclear cells (PBMC), isolated from blood samples collected from consented participants.

Exclusion criteria

Exclusion criteria: Specimen types other than PBMC

Design outcomes

Primary

Measure	Time frame
The clinical validity of the PhenoSense HIV mAb Assay will be established if the participants  identified with TAB- and ZAB-susceptible HIV-1 by the assay demonstrate virologic outcomes consistent with  clinical benefit from LEN + TAB + ZAB therapy, as measured by the proportion of participants achieving HIV-1 RNA < 50 copies/mL at Week 52	—

Countries

Argentina, Australia, Canada, France, Germany, Italy, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactT Battersby

Gilead Sciences

clinical.trials@gilead.com+01 650 574 3000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 10, 2026