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

NCT05271370 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-10-30

Study results available
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Summary

This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC (subcutaneous) monotherapy to maintain viral suppression after initial 48 weeks in virologically suppressed subjects.

Consenting subjects will continue weekly PRO 140 350mg, 525mg, or 700mg monotherapy during the Treatment Extension Phase with the one-week overlap of existing retroviral regimen and PRO 140 350mg, 525mg, or 700 mg at the end of the treatment in subjects who do not experience virologic failure.

Conditions

Interventions

DRUG

PRO 140 350

Pro140 SC injection 350 mg

DRUG

PRO 140 525

525 mg

DRUG

PRO 140 700

700 mg

Sponsors & Collaborators

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacob Lalezari, MD · CytoDyn, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2022-06-20
Completion
2022-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271370 on ClinicalTrials.gov