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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

February 28, 2018

Study Completion Date

July 31, 2018

Conditions
HIV
Interventions
DRUG

PRO 140

PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.

DRUG

Placebo

DRUG

Optimized Background Regimen

Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.

Trial Locations (36)

10001

CD02 Investigational site, New York

10011

CD02 Investigational site, New York

13210

CD02 Investigational site, Syracuse

20009

CD02 Investigational Site, Washington D.C.

20017

CD02 Investigational site, Washington D.C.

20852

CD02 Investigational site, Miami

22003

CD02 Investigational Site, Annandale

28226

CD02 Investigational site, Charlotte

32803

CD02 Investigational site, Orlando

33136

CD02 Investigational site, Miami

33139

CD02 Investigational site, Miami Beach

33169

CD02 Investigational Site, Miami

33401

CD02 Investigational site, West Palm Beach

33761

CD02 Investigational Site, Clearwater

34982

CD02 Investigational site, Ft. Pierce

45267

CD02 Investigational site, Cincinnati

60613

CD02 Investigational site, Chicago

67214

CD02 Investigational site, Wichita

75231

CD02 Investigational site, Dallas

77004

CD02 Investigational Site, Houston

77098

CD02 Investigational site, Houston

77301

CD02 Investigational Site, Bellaire

78705

CD02 Investigational Site, Austin

89109

E Study Site, Las Vegas

90008

CD02 Investigational site, Los Angeles

90036

CD02 Investigational Site, Los Angeles

90813

CD02 Investigational site, Long Beach

92262

CD02 Investigational site, Palm Springs

92708

CD02 Investigational site, Fountain Valley

94115

CD02 Investigational Site, San Francisco

94118

CD02 Investigational site, San Francisco

99202

CD02 Investigational Site, Spokane

06510

CD02 Investigational Site, New Haven

06850

CD02 Investigational site, Norwalk

00716-2347

CD02 Investigational site, Ponce

00909

CD02 Investigational site, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CytoDyn, Inc.

INDUSTRY

NCT02483078 - Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140 | Biotech Hunter | Biotech Hunter