Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection

Study Overview
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Brief Summary
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The purpose of this study is: To assess the antiviral activity of PRO 140 To assess the safety and tolerability of PRO 140 To generate additional PK, PD and safety data of PRO 140

Official Title
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A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection

Conditions
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HIV -1 Infection, HIV Infections

Intervention / Treatment
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* Drug: PRO 140 (humanized monoclonal antibody to CCR5)
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males & females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities) Screening plasma HIV-1 RNA ≥ 5,000 copies/mL CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3 Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit Clinically normal or not clinically significant (NCS) resting electrocardiogram Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit & a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, & be non-lactating. Male & female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59. Exclusion Criteria: CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study. History of active hepatitis within the previous 24 wks Prior use of any entry, attachment, CCR5 co-receptor 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>PRO 140 for three single SC doses: Days 1, 8, and 15 | Drug: PRO 140 (humanized monoclonal antibody to CCR5)<br> <br> |
| Active Comparator: Arm 2<br>PRO 140 for three single SC doses: Days 1, 8 and 15 | Drug: PRO 140 (humanized monoclonal antibody to CCR5)<br> <br> |
| Active Comparator: Arm 3<br>PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8 | Drug: PRO 140 (humanized monoclonal antibody to CCR5)<br> <br> |
| Placebo Comparator: Arm 4<br>PBO for three single SC doses: Days 1, 8 and 15 | Drug: Placebo Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL). | The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL). | 59 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Treatment Naïve