Overview

This trial is active, not recruiting.

Conditions hiv, human immunodeficiency virus
Treatment pro 140 350mg weekly sq injection.
Phase phase 2
Sponsor CytoDyn, Inc.
Start date May 2014
End date September 2016
Trial size 43 participants
Trial identifier NCT02175680, PRO 140_CD 01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
PRO 140 350mg weekly SQ injection.
pro 140 350mg weekly sq injection.
CCR5 Antagonist

Primary Outcomes

Measure
Time to Virologic Failure after initiating PRO 140 monotherapy. Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days.
time frame: 14 Weeks

Secondary Outcomes

Measure
Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14.
time frame: 14 Weeks
Mean change in Viral Load (HIV-1 RNA levels), at each visit within the 14-week treatment phase
time frame: 14 Weeks
Mean change in Viral Load (HIV-1 RNA levels), within the 14-week treatment phase
time frame: 14 Weeks
Mean change in CD4 cell count, at each visit within the 14-week treatment phase
time frame: 14 Weeks
Mean change in CD4 cell count, within the 14-week treatment phase
time frame: 14 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Males and females, age ≥18 years 2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay 3. On stable antiretroviral therapy for last 12 months 4. Subject has two or more potential alternative antiretroviral regimen options to consider. 5. No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12 months prior to Screening Visit 6. Nadir CD4 cell count of >200 cells/mm3 Exclusion Criteria: 1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the Screening Visit 2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg) 3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition 4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including PRO 140. 5. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Additional Information

Official title A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection
Principal investigator Jacob Lalezari, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by CytoDyn, Inc..