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Study of intravenous PRO 140 or placebo in adult patients with HIV
ISRCTN ISRCTN45537485
DOI 10.1186/ISRCTN45537485
ClinicalTrials.gov identifier
EudraCT number
Public title Study of intravenous PRO 140 or placebo in adult patients with HIV
Scientific title A phase Ib, double-blind, randomized, dose-cohort escalation study of intravenous PRO 140 or placebo in adult patients with HIV-1 infection
Acronym N/A
Serial number at source PRO140 1302
Study hypothesis The primary efficacy measure is the maximal change from baseline in viral load.
Lay summary
Ethics approval Western Institutional Review Board, 3535 Seventh Ave., SW, Olympia, Washington 98502-5010, USA. Date of approval: 10/04/2005 (ref: 1071726)
Study design Multi-center, double-blind, randomised, placebo-controlled study.
Countries of recruitment United States of America
Disease/condition/study domain HIV-1 infection
Participants - inclusion criteria 1. Males and females, at least age 18 years
2. Screening plasma HIV-1 RNA at least 5,000 copies/mL
3. CD4+ count at least 250 cells/mm3 and no documented count equal to or below 200 cells/mm3
4. Subject has not taken any antiretroviral therapy within three months of the screening visit
5. CCR5-tropic virus based on viral tropism assessment at screening visit
6. Normal resting 12-lead electrocardiogram at screening visit
7. Females of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result recorded within 72 hours prior to the first dose of study drug, and be non-lactating
Participants - exclusion criteria 1. Females who are pregnant or lactating
2. CXCR4-tropic virus or dual-tropic (R5X4) virus based on the Trofile™ assay at the screening visit
3. Previous participation in an experimental drug trial(s) within 30 days of the screening visit
4. History of hepatitis within the previous six months
5. Any prior treatment with any entry, attachment, co-receptor, or fusion inhibitor, investigational or approved
Anticipated start date 08/12/2005
Anticipated end date 08/02/2007
Status of trial Completed
Patient information material
Target number of participants 40
Interventions Participants were randomly allocated to the following four groups (three intervention and one control groups):

Intervention - PRO 140, 10 mg/mL solution for intravenous injection:
Group 1: 0.5 mg/kg single dose
Group 2: 2 mg/kg single dose
Group 3: 5 mg/kg single dose

Control treatment:
Group 4: Placebo, single dose
Primary outcome measure(s) To evaluate the tolerability of a single, intravenous dose of PRO 140 within 59 days
Secondary outcome measure(s) 1. To assess the effect on viral load of ascending single doses of PRO 140 within 59 days
2. To determine the pharmacokinetics of PRO 140 within 59 days
Sources of funding Progenics Pharmaceuticals, Inc. (USA)
Trial website
Publications
Contact name Dr  Stephen  Morris
  Address Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
  City/town Tarrytown
  Zip/Postcode 10591
  Country United States of America
Sponsor Progenics Pharmaceuticals, Inc. (USA)
  Address c/o Dr Stephen Morris
777 Old Saw Mill River Road
  City/town Tarrytown
  Zip/Postcode 10591
  Country United States of America
  Sponsor website: http://www.progenics.com
Date applied 11/02/2008
Last edited 15/02/2008
Date ISRCTN assigned 15/02/2008
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