Loading clinical trials...

PRO 140 for Human Immunodeficiency Virus Infection | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

PRO 140 for Human Immunodeficiency Virus Infection

PRO 140 2103: A Phase 2a, Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection

NCT02257788•Drexel University

View on ClinicalTrials.gov

Summary

PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.

Detailed Description

Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females, age ≥18 years
•2. Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
•3. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
•4. CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
•5. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
•6. Clinically normal resting 12-lead ECG at screening visit
•7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through three weeks after the last administered subcutaneous dose of PRO 140.

Exclusion Criteria

•1. CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
•2. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
•3. Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
•4. Chronic hepatitis
•5. Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
•6. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

Locations (7)

Stanford University (Stanford AIDS Clinical Trials Unit)

Stanford, California, United States

University of Colorado Denver (Colorado ACTU)

Denver, Colorado, United States

Washington University in St. Louis

St Louis, Missouri, United States

University of Rochester Medical Center

Rochester, New York, United States

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Health Science Center at Houston (Houston AIDS Research team (HART)

Houston, Texas, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

March 9, 2017

Conditions

HIV

Interventions

PRO 140

BIOLOGICAL

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

View study

RECRUITING

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

View study

RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PRO 140 for Human Immunodeficiency Virus Infection

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Thinking and Memory Problems in People With HIV

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption