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

HIV Infections Clinical Trial

Official title:

A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642707
• Other study ID #: PRO 140 2101
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2008
• Last updated: December 14, 2015
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2015
• Source: CytoDyn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: National Institute of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2008
• Est. primary completion date: November 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+ 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV -1 Infection
• HIV Infections
• Infection

Intervention

Drug:
• PRO 140 (humanized monoclonal antibody to CCR5)

• Placebo Comparator

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 (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).	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

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