Condition category
Infections and Infestations
Date applied
11/02/2008
Date assigned
15/02/2008
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Morris

ORCID ID

Contact details

Progenics Pharmaceuticals
Inc.
777 Old Saw Mill River Road
Tarrytown
10591
United States of America

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

http://www.progenics.com

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

Publication citations

Additional files

Editorial Notes