Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000715
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and ParenteralOral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and ParenteralOral Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Pneumonia in AIDS
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the safety and effectiveness of drug therapy with aerosolized pentamidine PEN with that of conventional therapy sulfamethoxazole plus trimethoprim SMXTMP in the treatment of Pneumocystis carinii pneumonia PCP in patients who have AIDS are HIV positive or are at high risk for HIV infection
New treatments are needed for PCP a common lung infection in patients with AIDS because many patients treated with the two standard treatments PEN given by injections and SMXTMP have had adverse effects that required a change in treatment There is also a high relapse rate after the standard treatments Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP and causes few adverse effects
New treatments are needed for PCP a common lung infection in patients with AIDS because many patients treated with the two standard treatments PEN given by injections and SMXTMP have had adverse effects that required a change in treatment There is also a high relapse rate after the standard treatments Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP and causes few adverse effects
Detailed Description:
New treatments are needed for PCP a common lung infection in patients with AIDS because many patients treated with the two standard treatments PEN given by injections and SMXTMP have had adverse effects that required a change in treatment There is also a high relapse rate after the standard treatments Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP and causes few adverse effects
Patients entered in the study are randomly assigned to aerosolized PEN or to intravenous SMXTMP for a 21-day trial SMXTMP is given 4 times a day and aerosolized PEN once a day Doses are determined by body size Patients who receive aerosolized PEN also receive a placebo intravenous injection and patients who receive SMXTMP also receive a placebo aerosol Patients are hospitalized at least 5 days Patients who improve may be discharged after 5 days at the discretion of the attending physician Discharged patients continue the study with oral SMXTMP and aerosolized placebo or aerosolized PEN and oral placebo Patients who fail to respond or who develop severe adverse effects are switched to intravenous PEN or other standard therapy During the 21-day trial zidovudine AZT may not be used AZT may be resumed after therapy for the acute PCP episode is completed
Patients entered in the study are randomly assigned to aerosolized PEN or to intravenous SMXTMP for a 21-day trial SMXTMP is given 4 times a day and aerosolized PEN once a day Doses are determined by body size Patients who receive aerosolized PEN also receive a placebo intravenous injection and patients who receive SMXTMP also receive a placebo aerosol Patients are hospitalized at least 5 days Patients who improve may be discharged after 5 days at the discretion of the attending physician Discharged patients continue the study with oral SMXTMP and aerosolized placebo or aerosolized PEN and oral placebo Patients who fail to respond or who develop severe adverse effects are switched to intravenous PEN or other standard therapy During the 21-day trial zidovudine AZT may not be used AZT may be resumed after therapy for the acute PCP episode is completed
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11015 | REGISTRY | DAIDS ES Registry Number | None |