An Extension of Protocol PRO 140_CD01 TS Study

• ClinicalTrials.gov Identifier: NCT02355184
• Recruitment Status: Active, not recruiting
• First Posted: February 4, 2015
• Last Update Posted: February 8, 2019
• Sponsor: CytoDyn, Inc.
• Information provided by (Responsible Party): CytoDyn, Inc.

Study Description

Brief Summary:

This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who were stable on combination antiretroviral therapy and completed 12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing virologic failure.

Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks. Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of existing retroviral regimen and PRO 140 at the end of the treatment extension phase in subjects who do not experience virologic failure.

Condition or disease	Intervention/treatment	Phase
HIV; Human Immunodeficiency Virus	Drug: PRO 140 350mg weekly SQ injection.	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 28 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extension of Protocol PRO140_CD01 to Evaluate Long-term Suppression of HIV-1 Replication Following Substitution of Stable Combination ART With PRO 140 (Monoclonal CCR5 Antibody) Monotherapy for Additional 160 Weeks in Adult Subjects w/ HIV-1
• Study Start Date: November 2014
• Estimated Primary Completion Date: March 2020
• Estimated Study Completion Date: September 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: PRO 140; PRO 140 350mg weekly SQ injection.	Drug: PRO 140 350mg weekly SQ injection.; CCR5 Antagonist; Other Name: PRO 140

Outcome Measures

Primary Outcome Measures :

1. Time to virologic failure after initiating PRO 140 monotherapy. [ Time Frame: 160 weeks ]
   Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days.

Secondary Outcome Measures :

1. Proportion of Participants with virologic failure after initiating PRO 140 monotherapy. [ Time Frame: Up to160 weeks ]
2. Mean change in viral load (HIV-1 RNA levels) [ Time Frame: Up to 160 weeks ]
3. Mean change in CD4 cell count [ Time Frame: Up to 160 weeks ]
4. Change in Quality of Life metrics (up to TE107) [ Time Frame: Up to 160 weeks ]

Other Outcome Measures:

1. Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants(using Visual Analogue Scale) and by investigator-evaluation of injection site reactions. [ Time Frame: Up to 160 weeks ]
2. Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: Up to 160 weeks ]
3. Frequency of Treatment-emergent serious adverse events [ Time Frame: Up to 160 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without experiencing virologic failure.
2. Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug.
3. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

1. Not currently enrolled in PRO140_CD01 Treatment Substitution Study
2. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
3. Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
4. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
5. Unexplained temperature >38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose
6. Diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) that in the opinion of the primary care provider and/or site investigator would interfere with the subject's successful completion of the study requirements
7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Contacts and Locations

Locations

United States, California

CD01-Extension Investigational Site

San Francisco, California, United States, 94115

Sponsors and Collaborators

CytoDyn, Inc.

More Information

• Responsible Party: CytoDyn, Inc.
• ClinicalTrials.gov Identifier: NCT02355184 History of Changes
• Other Study ID Numbers: PRO 140_CD 01-Extension
• First Posted: February 4, 2015
• Last Update Posted: February 8, 2019
• Last Verified: February 2019

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases; PRO-140 monoclonal antibody; HIV Antibodies; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs