An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study

Hiv Clinical Trial

Official title:

An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02990858
• Other study ID #: PRO 140 _CD02 Extension
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 3, 2016
• Est. completion date: August 2022

Study information

• Verified date: September 2021
• Source: CytoDyn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with CCR5-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: August 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study.

1. Subjects who have completed 24 weeks of treatment in PRO 140_CD 02 study, and Investigator believes subject requires continued access to PRO 140 in order to continue deriving clinical benefit and maintain HIV-1 viral suppression

2. HIV-1 RNA = 50 copies/ml at T23 Visit in PRO140_CD02 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 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: Potential subjects meeting any of the following criteria will be excluded from enrollment.

1. Not currently enrolled in PRO 140_CD 02 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. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hiv
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Drug:
• PRO 140 SC injections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CytoDyn, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period		through study completion, an average of 4 year
Secondary	Mean change in CD4 cell count at the conclusion of treatment period		through study completion, an average of 4 year
Secondary	Emergence of Dual/Mixed (D/M)- and CXCR4-tropic virus in patients who had exclusive CCR5- tropic virus at study entry.		through study completion, an average of 4 year
Secondary	Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions		through study completion, an average of 4 year
Secondary	Frequency of treatment-related adverse events resulting in study drug discontinuation		through study completion, an average of 4 year
Secondary	Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale		through study completion, an average of 4 year
Secondary	Frequency of treatment-emergent serious adverse events		through study completion, an average of 4 year