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
Scientific
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown
10591
United States of America
Study information
Study design | Multi-center, double-blind, randomised, placebo-controlled study. |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Phase I |
Drug / device / biological / vaccine name(s) | PRO 140 |
Primary outcome measure | 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 study start date | 08/12/2005 |
Completion date | 08/02/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Progenics Pharmaceuticals, Inc.
Tarrytown
10591
United States of America
10591
United States of America
Sponsor information
Progenics Pharmaceuticals, Inc. (USA)
Industry
Industry
c/o Dr Stephen Morris
777 Old Saw Mill River Road
Tarrytown
10591
United States of America
Website | http://www.progenics.com |
---|---|
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.