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An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02990858
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : October 5, 2021
Information provided by (Responsible Party):
CytoDyn, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hiv Human Immunodeficiency Virus Drug: PRO 140 SC injections Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Actual Study Start Date : November 3, 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: PRO 140 Drug: PRO 140 SC injections

Primary Outcome Measures :
  1. Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period [ Time Frame: through study completion, an average of 4 year ]

Secondary Outcome Measures :
  1. Mean change in CD4 cell count at the conclusion of treatment period [ Time Frame: through study completion, an average of 4 year ]
  2. Emergence of Dual/Mixed (D/M)- and CXCR4-tropic virus in patients who had exclusive CCR5- tropic virus at study entry. [ Time Frame: through study completion, an average of 4 year ]
  3. Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions [ Time Frame: through study completion, an average of 4 year ]
  4. Frequency of treatment-related adverse events resulting in study drug discontinuation [ Time Frame: through study completion, an average of 4 year ]
  5. Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: through study completion, an average of 4 year ]
  6. Frequency of treatment-emergent serious adverse events [ Time Frame: through study completion, an average of 4 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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
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Responsible Party: CytoDyn, Inc. Identifier: NCT02990858    
Other Study ID Numbers: PRO 140 _CD02 Extension
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents