PRO 140 by IV Administration in Adults 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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this study is:

1. To assess and characterize the PK and PD of PRO 140 administered IV
2. To assess the antiviral activity of PRO 140
3. To assess the safety and tolerability of PRO 140

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

10 mg/kg PRO 140, one IV dose (N=10)

Group Type EXPERIMENTAL

PRO 140

Intervention Type DRUG

10 mg/kg PRO 140, one IV dose (N=10)

Arm 2

5 mg/kg PRO 140, one IV dose (N=10)

Group Type EXPERIMENTAL

PRO 140

Intervention Type DRUG

5 mg/kg PRO 140, one IV dose (N=10)

Arm 3

Placebo, one IV dose (N=10)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

PBO, one IV dose (N=10)

Interventions

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PRO 140

10 mg/kg PRO 140, one IV dose (N=10)

Intervention Type DRUG

PRO 140

5 mg/kg PRO 140, one IV dose (N=10)

Intervention Type DRUG

Placebo

PBO, one IV dose (N=10)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No