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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613379
• Other study ID #: PRO 140 2301
• Secondary ID: 1U19AI066329
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2008
• Last updated: November 16, 2015
• Start date: December 2007
• Est. completion date: August 2008

Study information

• Verified date: July 2013
• Source: CytoDyn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Infection

Intervention

Drug:
• PRO 140
10 mg/kg PRO 140, one IV dose (N=10)
• PRO 140
5 mg/kg PRO 140, one IV dose (N=10)
• Placebo
PBO, one IV dose (N=10)

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
CytoDyn, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Sponsor website