Study of intravenous PRO 140 or placebo in adult patients with HIV

ISRCTN ISRCTN45537485
DOI https://doi.org/10.1186/ISRCTN45537485
Secondary identifying numbers PRO140 1302
Submission date
11/02/2008
Registration date
15/02/2008
Last edited
30/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Morris
Scientific

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

Study information

Study designMulti-center, double-blind, randomised, placebo-controlled study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA phase Ib, double-blind, randomized, dose-cohort escalation study of intravenous PRO 140 or placebo in adult patients with HIV-1 infection
Study objectivesThe primary efficacy measure is the maximal change from baseline in viral load.
Ethics approval(s)Western Institutional Review Board, 3535 Seventh Ave., SW, Olympia, Washington 98502-5010, USA. Date of approval: 10/04/2005 (ref: 1071726)
Health condition(s) or problem(s) studiedHIV-1 infection
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)PRO 140
Primary outcome measureTo evaluate the tolerability of a single, intravenous dose of PRO 140 within 59 days
Secondary outcome measures1. 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 study start date08/12/2005
Completion date08/02/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Total final enrolment39
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment08/12/2005
Date of final enrolment08/02/2007

Locations

Countries of recruitment

  • United States of America

Study participating centre

Progenics Pharmaceuticals, Inc.
Tarrytown
10591
United States of America

Sponsor information

Progenics Pharmaceuticals, Inc. (USA)
Industry

c/o Dr Stephen Morris
777 Old Saw Mill River Road
Tarrytown
10591
United States of America

Website http://www.progenics.com
ROR logo "ROR" https://ror.org/023ka9926

Funders

Funder type

Industry

Progenics Pharmaceuticals, Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2008 30/12/2020 Yes No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.