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An Extension of Protocol PRO 140_CD01 TS Study

Primary Purpose

HIV, Human Immunodeficiency Virus

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PRO 140 350mg weekly SQ injection.

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without experiencing virologic failure.
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.
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:

Not currently enrolled in PRO140_CD01 Treatment Substitution Study
Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
Unexplained temperature >38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose
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
Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Sites / Locations

CD01-Extension Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRO 140

Arm Description

PRO 140 350mg weekly SQ injection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of Participants with virologic failure after initiating PRO 140 monotherapy.

Mean change in viral load (HIV-1 RNA levels)

Mean change in CD4 cell count

Change in Quality of Life metrics (up to TE107)

Full Information

NCT ID

NCT02355184

First Posted

January 30, 2015

Last Updated

September 28, 2021

Sponsor

CytoDyn, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02355184

Brief Title

An Extension of Protocol PRO 140_CD01 TS Study

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 Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 18, 2014 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CytoDyn, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV, Human Immunodeficiency Virus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRO 140

Arm Type

Experimental

Arm Description

PRO 140 350mg weekly SQ injection.

Intervention Type

Drug

Intervention Name(s)

PRO 140 350mg weekly SQ injection.

Other Intervention Name(s)

PRO 140

Intervention Description

CCR5 Antagonist

Primary Outcome Measure Information:

Title

Time to virologic failure after initiating PRO 140 monotherapy.

Description

Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days.

Time Frame

160 weeks

Secondary Outcome Measure Information:

Title

Proportion of Participants with virologic failure after initiating PRO 140 monotherapy.

Time Frame

Up to160 weeks

Title

Mean change in viral load (HIV-1 RNA levels)

Time Frame

Up to 160 weeks

Title

Mean change in CD4 cell count

Time Frame

Up to 160 weeks

Title

Change in Quality of Life metrics (up to TE107)

Time Frame

Up to 160 weeks

Other Pre-specified Outcome Measures:

Title

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

Title

Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale

Time Frame

Up to 160 weeks

Title

Frequency of Treatment-emergent serious adverse events

Time Frame

Up to 160 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without experiencing virologic failure. 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. 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: Not currently enrolled in PRO140_CD01 Treatment Substitution Study Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition Laboratory test values ≥ grade 4 DAIDS laboratory abnormality. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study Unexplained temperature >38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose 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 Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Facility Information:

Facility Name

CD01-Extension Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35358290

Citation

Chang XL, Reed JS, Webb GM, Wu HL, Le J, Bateman KB, Greene JM, Pessoa C, Waytashek C, Weber WC, Hwang J, Fischer M, Moats C, Shiel O, Bochart RM, Crank H, Siess D, Giobbi T, Torgerson J, Agnor R, Gao L, Dhody K, Lalezari JP, Bandar IS, Carnate AM, Pang AS, Corley MJ, Kelly S, Pourhassan N, Smedley J, Bimber BN, Hansen SG, Ndhlovu LC, Sacha JB. Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species. PLoS Pathog. 2022 Mar 31;18(3):e1010396. doi: 10.1371/journal.ppat.1010396. eCollection 2022 Mar.

Results Reference

derived

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An Extension of Protocol PRO 140_CD01 TS Study

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