Clinical trials / NCT05271370
NCT05271370Phase 2, phase 3Terminated

An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

Study sponsor: CytoDyn, Inc.

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-06-20Actual
Enrollment · participants56Actual
Source updated2025-10-30Last update listed in the registry record
Version history

Changes to this trial

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· 5 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Long term clinical safety of PRO 140 350mg, 525, or 700 mg monotherapy regimen will be measured based on participants With Treatment-Related Adverse Events Measure: Proportion of participants experiencing virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured

+ After

Measure: Long Term Clinical Safety of PRO 140 Monotherapy by Assessing the Number of Participants With Grade 2, 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale, and the Number of Participants With Treatment-emergent Serious Adverse Events. Measure: Proportion of Participants Experiencing Virologic Failure for All Subjects Within Each Treatment Group.

Participant count type changed

− Before

Estimated

+ After

Actual

Completion date type changed

− Before

Estimated

+ After

Actual

Primary completion date changed

− Before

20 Dec 2022

+ After

20 Jun 2022

Recruitment status changed

− Before

Active not recruiting

+ After

Terminated

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