An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

• ClinicalTrials.gov Identifier: NCT05271370
• Recruitment Status: Active, not recruiting
• First Posted: March 9, 2022
• Last Update Posted: March 9, 2022
• Sponsor: CytoDyn, Inc.
• Information provided by (Responsible Party): CytoDyn, Inc.

Tracking Information

• First Submitted Date: January 13, 2022
• First Posted Date: March 9, 2022
• Last Update Posted Date: March 9, 2022
• Actual Study Start Date: August 29, 2017
• Estimated Primary Completion Date: December 20, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 4, 2022)

• Long term clinical safety of PRO 140 350mg, 525, or 700 mg monotherapy regimen will be measured based on participants With Treatment-Related Adverse Events [ Time Frame: 200 weeks ]
• Proportion of participants experiencing virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 4, 2022)

• Time to virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]
• Proportion of participants achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]
• Time to achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]
• Proportion of virologic failure subjects achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) with re-initiation of previous baseline antiretroviral regimen for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]
• Mean change in CD4 cell count, at each visit within the Treatment Phase for all subjects will and within each treatment group will be measured [ Time Frame: 200 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study
• Official Title: An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

Brief Summary

This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC monotherapy to maintain viral suppression after initial 48 weeks in virologically suppressed subjects.

Consenting subjects will continue weekly PRO 140 350mg, 525mg, or 700mg monotherapy during the Treatment Extension Phase with the one week overlap of existing retroviral regimen and PRO 140 350mg, 525mg, or 700 mg at the end of the treatment in subjects who do not experience virologic failure.

• Detailed Description: The objective is to assess the long-term safety of using PRO 140 350mg, 525mg, or 700mg SC as single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV-1-infection

Intervention

• Drug: PRO 140 350
  Pro140 SC injection 350 mg
• Drug: PRO 140 525
  525 mg
• Drug: PRO 140 700
  700 mg

Study Arms

• Experimental: PRO 140 350 mg
  PRO 140 350mg weekly SQ injection.
  Intervention: Drug: PRO 140 350
• Experimental: PRO 140 525 mg
  PRO 140 525mg weekly SQ injection.
  Intervention: Drug: PRO 140 525
• Experimental: PRO 140 700 mg
  PRO 140 700mg weekly SQ injection.
  Intervention: Drug: PRO 140 700

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 4, 2022): 56
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 10, 2023
• Estimated Primary Completion Date: December 20, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subjects who have completed 48 weeks of treatment in PRO140_CD03 study.
2. Last known Plasma HIV-1 RNA < 50 copies/mL within PRO140_CD03 study.
3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
4. 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_CD03 study.
2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma).
3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
4. Subjects weighing < 35kg.
5. History of anaphylaxis to any oral or parenteral drugs.

6. History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin).

   Note: Subjects with well-controlled bleeding disorder while on stable anti-coagulant therapy dose with documented stable INRs can be enrolled as per discretion of the Investigator.

7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05271370
• Other Study ID Numbers: PRO 140_CD03 Extension
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: CytoDyn, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: CytoDyn, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: CytoDyn, Inc.
• Verification Date: March 2022