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Completed Phase 2Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02483078

Public ClinicalTrials.gov record NCT02483078. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 10:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02483078
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
CytoDyn, Inc.
Industry
Enrollment
52 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2015 (Actual)
Primary completion
Feb 2018 (Actual)
Completion
Jul 2018 (Actual)
Last update posted
Nov 3, 2022

2015 – 2018

United States locations

U.S. sites
34
U.S. states
13
U.S. cities
27
Facility City State ZIP Site status
CD02 Investigational site Fountain Valley California 92708 —
CD02 Investigational site Long Beach California 90813 —
CD02 Investigational site Los Angeles California 90008 —
CD02 Investigational Site Los Angeles California 90036 —
CD02 Investigational site Palm Springs California 92262 —
CD02 Investigational Site San Francisco California 94115 —
CD02 Investigational site San Francisco California 94118 —
CD02 Investigational Site New Haven Connecticut 06510 —
CD02 Investigational site Norwalk Connecticut 06850 —
CD02 Investigational Site Washington D.C. District of Columbia 20009 —
CD02 Investigational site Washington D.C. District of Columbia 20017 —
CD02 Investigational Site Clearwater Florida 33761 —
CD02 Investigational site Ft. Pierce Florida 34982 —
CD02 Investigational site Miami Florida 20852 —
CD02 Investigational site Miami Florida 33136 —
CD02 Investigational Site Miami Florida 33169 —
CD02 Investigational site Miami Beach Florida 33139 —
CD02 Investigational site Orlando Florida 32803 —
CD02 Investigational site West Palm Beach Florida 33401 —
CD02 Investigational site Chicago Illinois 60613 —
CD02 Investigational site Wichita Kansas 67214 —
E Study Site Las Vegas Nevada 89109 —
CD02 Investigational site New York New York 10001 —
CD02 Investigational site New York New York 10011 —
CD02 Investigational site Syracuse New York 13210 —
CD02 Investigational site Charlotte North Carolina 28226 —
CD02 Investigational site Cincinnati Ohio 45267 —
CD02 Investigational Site Austin Texas 78705 —
CD02 Investigational Site Bellaire Texas 77301 —
CD02 Investigational site Dallas Texas 75231 —
CD02 Investigational Site Houston Texas 77004 —
CD02 Investigational site Houston Texas 77098 —
CD02 Investigational Site Annandale Virginia 22003 —
CD02 Investigational Site Spokane Washington 99202 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02483078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 3, 2022 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02483078 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →