Clinical trialNCT02483078CompletedPhase 2/PHASE3Interventional

Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140

SponsorCytoDyn, Inc.Enrollment52HIV

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or more drug classes with limited treatment options).The options may be limited as a result of drug antiviral class cross-resistance or documented treatment intolerance.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Edwin DeJesus, MD, FACP,
Orlando Immunology Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

36 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Cd02 Investigational Site
Ponce, PR, Puerto Rico
Cd02 Investigational Site
San Juan, Puerto Rico

United States

Cd02 Investigational Site
Fountain Valley, California, United States
Cd02 Investigational Site
Long Beach, California, United States
Cd02 Investigational Site
Los Angeles, California, United States
Cd02 Investigational Site
Los Angeles, California, United States
Cd02 Investigational Site
Palm Springs, California, United States
Cd02 Investigational Site
San Francisco, California, United States
Cd02 Investigational Site
San Francisco, California, United States
Cd02 Investigational Site
New Haven, Connecticut, United States
Cd02 Investigational Site
Norwalk, Connecticut, United States
Cd02 Investigational Site
Washington D.C., District of Columbia, United States
Cd02 Investigational Site
Washington D.C., District of Columbia, United States
Cd02 Investigational Site
Clearwater, Florida, United States
Cd02 Investigational Site
Ft. Pierce, Florida, United States
Cd02 Investigational Site
Miami, Florida, United States
Cd02 Investigational Site
Miami, Florida, United States
Cd02 Investigational Site
Miami, Florida, United States
Cd02 Investigational Site
Miami Beach, Florida, United States
Cd02 Investigational Site
Orlando, Florida, United States
Cd02 Investigational Site
West Palm Beach, Florida, United States
Cd02 Investigational Site
Chicago, Illinois, United States
Cd02 Investigational Site
Wichita, Kansas, United States
E Study Site
Las Vegas, Nevada, United States
Cd02 Investigational Site
New York, New York, United States
Cd02 Investigational Site
New York, New York, United States
Cd02 Investigational Site
Syracuse, New York, United States
Cd02 Investigational Site
Charlotte, North Carolina, United States
Cd02 Investigational Site
Cincinnati, Ohio, United States
Cd02 Investigational Site
Austin, Texas, United States
Cd02 Investigational Site
Bellaire, Texas, United States
Cd02 Investigational Site
Dallas, Texas, United States
Cd02 Investigational Site
Houston, Texas, United States
Cd02 Investigational Site
Houston, Texas, United States
Cd02 Investigational Site
Annandale, Virginia, United States
Cd02 Investigational Site
Spokane, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Optimized Background RegimenPRO 140Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2015
Primary completion: 28 Feb 2018
Completion: 31 Jul 2018
Last update posted: 3 Nov 2022
Registered enrollment: 52
Registry id: NCT02483078

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.