Last updated on February 2019

Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: HIV | HIV infection | AIDS Vaccines | HIV positive
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Males and females, age 18 years
  2. Receiving combination antiretroviral therapy for last 24 weeks
  3. No change in ART within last 4 weeks prior to Screening Visit
  4. Subject has two or more potential alternative approved ART drug options to consider.
  5. Exclusive CCR5-tropic virus at Screening Visit
  6. Plasma HIV-1 RNA < 50 copies/mL at Screening Visit
  7. CD4 cell count of > 200 cells/mm3 since initiation of anti-retroviral therapy
  8. CD4 cell count of > 350 cells/mm3 in preceding 24 weeks and at Screening Visit
  9. Laboratory values at Screening of:
  10. Absolute neutrophil count (ANC) 750/mm3
  11. Hemoglobin (Hb) 10.5 gm/dL (male) or 9.5 gm/dL (female)
  12. Platelets 75,000 /mm3
  13. Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN)
  14. Serum aspartate transaminase (SGOT/AST) < 5 x ULN
  15. Bilirubin (total) < 2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease
  16. Creatinine 1.5 x ULN
  17. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
  18. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception during the course of the study.
  19. 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. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile DNA Assay
  2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
  3. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
  4. Laboratory test values grade 4 DAIDS laboratory abnormality.
  5. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  6. Unexplained fever or clinically significant illness within 1 week prior to the first study dose
  7. Any vaccination within 2 weeks prior to the first study dose or during the study.
  8. Subjects who have failed on a maraviroc containing regimen.
  9. Subjects weighing < 35kg
  10. History of anaphylaxis to any oral or parenteral drugs
  11. History of Bleeding Disorder or patients on anti-coagulant therapy
  12. Participation in an experimental drug trial(s) within 30 days of the Screening Visit
  13. Any known allergy or antibodies to the study drug or excipients
  14. Treatment with any of the following:
  15. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
  16. Immunosuppressants within 60 days prior to the screening visit
  17. Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit
  18. Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception:
    • Subjects on inhaled, nasal, or topical steroids will not be excluded
  19. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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