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Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

NCT02175680 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-04-14

Study results available
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Summary

This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.

Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Conditions

  • HIV
  • Human Immunodeficiency Virus

Interventions

DRUG

PRO 140

CCR5 Antagonist

OTHER

Historical data

Historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days).

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacob Lalezari, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-16
Primary Completion
2015-02-02
Completion
2015-02-02

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 NCT02175680 on ClinicalTrials.gov