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

ISRCTN	ISRCTN45537485
DOI	https://doi.org/10.1186/ISRCTN45537485
Protocol serial number	PRO140 1302
Sponsor	Progenics Pharmaceuticals, Inc. (USA)
Funder	Progenics Pharmaceuticals, Inc. (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Stephen Morris
Scientific

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

Primary study design	Interventional
Study design	Multi-center, double-blind, randomised, placebo-controlled study.
Secondary study design	Randomised controlled trial
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
Study objectives	The 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) studied	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 / device / biological / vaccine name(s)	PRO 140
Primary outcome measure(s)	To evaluate the tolerability of a single, intravenous dose of PRO 140 within 59 days
Key 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
Completion date	08/02/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Total final enrolment	39
Key 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
Key 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
Date of first enrolment	08/12/2005
Date of final enrolment	08/02/2007

Progenics Pharmaceuticals, Inc.

Tarrytown
10591
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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

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