PRO 140 for Human Immunodeficiency Virus Infection
HIV
About this trial
This is an interventional treatment trial for HIV
Eligibility Criteria
Inclusion Criteria:
- Males and females, age ≥18 years
- Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
- Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
- Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- Clinically normal resting 12-lead ECG at screening visit
- Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through three weeks after the last administered subcutaneous dose of PRO 140.
Exclusion Criteria:
- CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
- Chronic hepatitis
- Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
- Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.
Sites / Locations
- Stanford University (Stanford AIDS Clinical Trials Unit)
- University of Colorado Denver (Colorado ACTU)
- Washington University in St. Louis
- University of Rochester Medical Center
- Drexel University College of Medicine
- University of Pennsylvania
- University of Texas Health Science Center at Houston (Houston AIDS Research team (HART)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Treatment Arm 1
Treatment Arm 2
Treatment Arm 3
Treatment Arm 4
PRO 140: one SC dose, 350 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
PRO 140: one SC loading dose, 700 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
PRO 140: one SC loading dose, 700 mg (day 1), followed by one single SC dose 350 mg (day 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)