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

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: PRO 140; Drug: Placebo

• Registration Number: NCT00613379
• Lead Sponsor: CytoDyn, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2013-04-12
• Results First Submitted QC: 2013-04-12
• Results First Posted: 2013-05-31
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	PRO 140	10 mg/kg PRO 140, one IV dose (N=10)
Arm 3	Placebo	Placebo, one IV dose (N=10)
Arm 2	PRO 140	5 mg/kg PRO 140, one IV dose (N=10)

Primary Outcome Measures

Name	Time	Method
Maximum Change in Viral Load Following Initiation of Treatment.	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