An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study

CytoDyn

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Human Immunodeficiency Virus (HIV)

Treatments: Drug: PRO 140

Study type: Interventional

Funder types: Industry

Identifiers

NCT02990858

PRO 140 _CD02 Extension

Details and patient eligibility

About

PRO 140_CD02 Extension study seeks to evaluate the long-term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized Background Therapy (OBT) in patients infected with Human Immunodeficiency virus (HIV-1).

Full description

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 C-C Chemokine Receptor Type 5 (CCR5)-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 or CD02_OpenLabel study.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 or CD02_OpenLabel 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 subcutaneous (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 or CD02_OpenLabel 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Leronlimab (PRO 140)

Experimental group

Description:

The treatment extension phase consists of weekly treatment injection of PRO 140 in addition to Optimized Background Therapy.

Treatment:

Drug: PRO 140