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

Phase 2

Completed

• Conditions: HIV -1 Infection; HIV Infections
• Interventions: Drug: PRO 140 (humanized monoclonal antibody to CCR5); Drug: Placebo Comparator

• Registration Number: NCT00642707
• Lead Sponsor: CytoDyn, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-25
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2013-04-12
• Results First Submitted QC: 2013-04-12
• Results First Posted: 2013-05-31
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	PRO 140 (humanized monoclonal antibody to CCR5)	PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8
Arm 4	Placebo Comparator	PBO for three single SC doses: Days 1, 8 and 15
Arm 1	PRO 140 (humanized monoclonal antibody to CCR5)	PRO 140 for three single SC doses: Days 1, 8, and 15
Arm 2	PRO 140 (humanized monoclonal antibody to CCR5)	PRO 140 for three single SC doses: Days 1, 8 and 15

Primary Outcome Measures

Name	Time	Method
Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).	59 days	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).

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States