PRO 140 by IV Administration in Adults With HIV-1 Infection

Study Overview
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Brief Summary
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The purpose of this study is: To assess and characterize the PK and PD of PRO 140 administered IV To assess the antiviral activity of PRO 140 To assess the safety and tolerability of PRO 140

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: PRO 140
* Drug: PRO 140
* Drug: Placebo


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+ T-lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3 Has not taken any anti-retroviral 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, experimental or approved.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>10 mg/kg PRO 140, one IV dose (N=10) | Drug: PRO 140<br>* 10 mg/kg PRO 140, one IV dose (N=10)<br>|
| Experimental: Arm 2<br>5 mg/kg PRO 140, one IV dose (N=10) | Drug: PRO 140<br>* 5 mg/kg PRO 140, one IV dose (N=10)<br>|
| Placebo Comparator: Arm 3<br>Placebo, one IV dose (N=10) | Drug: Placebo<br>* PBO, one IV dose (N=10)<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. | 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