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An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study

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ClinicalTrials.gov Identifier: NCT02990858
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
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)
Estimated Enrollment : 30 participants
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
Study Start Date : October 2016
Estimated Primary Completion Date : December 2020

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
ClinicalTrials.gov Identifier: NCT02990858     History of Changes
Other Study ID Numbers: PRO 140 _CD02 Extension
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
PRO-140 monoclonal antibody
HIV Antibodies
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs