Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PRO140 1302
Study information
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
Study hypothesis
The primary efficacy measure is the maximal change from baseline in viral load.
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
HIV-1 infection
Intervention
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
Intervention type
Drug
Phase
Phase I
Drug names
PRO 140
Primary outcome measures
To evaluate the tolerability of a single, intravenous dose of PRO 140 within 59 days
Secondary outcome measures
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
Overall trial start date
08/12/2005
Overall trial end date
08/02/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
08/12/2005
Recruitment end date
08/02/2007
Locations
Countries of recruitment
United States of America
Trial participating centre
Progenics Pharmaceuticals, Inc.
Tarrytown
10591
United States of America
Sponsor information
Organisation
Progenics Pharmaceuticals, Inc. (USA)
Sponsor details
c/o Dr Stephen Morris
777 Old Saw Mill River Road
Tarrytown
10591
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Progenics Pharmaceuticals, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary