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Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection

NCT02859961 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2026-03-04

Study results available
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Summary

This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry.

Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Conditions

Interventions

DRUG

PRO 140 (350 mg)

PRO 140 350 mg (175 mg/mL) SC injection per week

DRUG

PRO 140 (525 mg)

PRO 140 525 mg (175 mg/mL) SC injection per week

DRUG

PRO 140 (700 mg)

PRO 140 700 mg (175 mg/mL) SC injection per week

Sponsors & Collaborators

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacob Lalezari, MD · CytoDyn, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-07
Primary Completion
2020-09-16
Completion
2020-12-07
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 NCT02859961 on ClinicalTrials.gov