A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
|ClinicalTrials.gov Identifier: NCT00232635|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : February 12, 2010
- Pilot Study: A preliminary assessment of the exposure and safety of oral A-60444 in post-stem cell transplant patients with RSV infection.
- Main Study: To determine the antiviral effect of oral A-60444 versus placebo in post-stem cell transplant patients with RSV infection and to assess the safety of oral A-60444 in post-stem cell transplant patients with RSV infection.
- To study the pharmacokinetics of A-60444 in the presence of concomitant medications such as immunosuppressants and antifungals, in post-stem cell transplant patients with RSV infection.
Sample Size: Six patients will be included in the open, pilot phase of the study and there is an option to include a further 22 patients into the main, placebo-controlled study, depending on the pilot study findings. An independent Data Safety Monitoring Board will assess the findings of the pilot study.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus Infections||Drug: A-60444||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Safety and Efficacy of A-60444 in Adults With RSV Infection Following Stem Cell Transplantation|
|Study Start Date :||September 2005|
|Primary Completion Date :||July 2006|
|Study Completion Date :||July 2006|
- Reduction of viral load over time:
- 2-log reduction (by quantitative real time reverse transcription polymerase chain reaction [rtRT PCR]) in the RSV load of nasopharyngeal swabs in patients three days after treatment with A-60444, compared to patients treated with placebo
- Change in viral titre over treatment period
- Safety, pharmacokinetics (PK)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232635
|London, United Kingdom|
|Principal Investigator:||Stephen MacKinnon||Royal Free Hospital NHS Foundation Trust|