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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study is:

1. To assess the antiviral activity of PRO 140
2. To assess the safety and tolerability of PRO 140
3. To generate additional PK, PD and safety data of PRO 140

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Detailed Description

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Conditions

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HIV -1 Infection HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

PRO 140 for three single SC doses: Days 1, 8, and 15

Group Type ACTIVE_COMPARATOR

PRO 140 (humanized monoclonal antibody to CCR5)

Intervention Type DRUG

Arm 2

PRO 140 for three single SC doses: Days 1, 8 and 15

Group Type ACTIVE_COMPARATOR

PRO 140 (humanized monoclonal antibody to CCR5)

Intervention Type DRUG

Arm 3

PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8

Group Type ACTIVE_COMPARATOR

PRO 140 (humanized monoclonal antibody to CCR5)

Intervention Type DRUG

Arm 4

PBO for three single SC doses: Days 1, 8 and 15

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Interventions

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PRO 140 (humanized monoclonal antibody to CCR5)

Intervention Type DRUG

Placebo Comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
3. CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count \< or = 250 cells/mm3
4. Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit
5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
7. 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

1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
3. History of active hepatitis within the previous 24 wks
4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, including PRO 140, experimental or approved.
5. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No