Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000727
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine AZT
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Controlled Comparative Trial of Trimethoprim - Sulfamethoxazole Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine AZT
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 determine if the drug combination sulfamethoxazole-trimethoprim SMX-TMP given by mouth and the drug pentamidine PEN given by inhaled aerosol are effective in preventing a relapse of Pneumocystis carinii pneumonia PCP when they are given to patients who have recovered from a first episode of PCP and are being given zidovudine AZT to treat primary HIV infection
AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP However PCP recurs in about 43 percent of patients receiving AZT indicating a need for other treatments to reduce the relapse rate
The two medications to be tested in this study SMXTMP and aerosolized PEN have also been partially effective in preventing recurrence of PCP It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone
AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP However PCP recurs in about 43 percent of patients receiving AZT indicating a need for other treatments to reduce the relapse rate
The two medications to be tested in this study SMXTMP and aerosolized PEN have also been partially effective in preventing recurrence of PCP It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone
Detailed Description:
AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP However PCP recurs in about 43 percent of patients receiving AZT indicating a need for other treatments to reduce the relapse rate
The two medications to be tested in this study SMXTMP and aerosolized PEN have also been partially effective in preventing recurrence of PCP It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone
Patients receive the standard dose of AZT at study entry Low body weight patients receive AZT at a lower dose Patients are randomly assigned to one of two medications intended to prevent the recurrence of PCP Patients assigned to SMXTMP will take 1 capsule which contains both drugs once a day for 1 year Patients assigned to PEN will have 1 aerosol treatment every 4 weeks for 1 year Blood will be drawn at intervals in order to estimate blood levels of the drugs and to detect any adverse effects from the drugs Note Earlier versions of this protocol reflect its original design as a 3-arm study comparing aerosolized PEN SMXTMP and pyrimethamine-sulfadoxine as secondary prophylaxis of PCP in AIDS patients receiving AZT In order to reduce the effective sample size and permit the completion of accrual in a reasonable period of time the pyrimethamine - sulfadoxine arm of this study has been discontinued Patients randomized to this arm will be continued in this study on the original randomized therapy Management of these patients will follow that described for SMXTMP in the latest protocol version AMENDED Lower dose of AZT allowed
The two medications to be tested in this study SMXTMP and aerosolized PEN have also been partially effective in preventing recurrence of PCP It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone
Patients receive the standard dose of AZT at study entry Low body weight patients receive AZT at a lower dose Patients are randomly assigned to one of two medications intended to prevent the recurrence of PCP Patients assigned to SMXTMP will take 1 capsule which contains both drugs once a day for 1 year Patients assigned to PEN will have 1 aerosol treatment every 4 weeks for 1 year Blood will be drawn at intervals in order to estimate blood levels of the drugs and to detect any adverse effects from the drugs Note Earlier versions of this protocol reflect its original design as a 3-arm study comparing aerosolized PEN SMXTMP and pyrimethamine-sulfadoxine as secondary prophylaxis of PCP in AIDS patients receiving AZT In order to reduce the effective sample size and permit the completion of accrual in a reasonable period of time the pyrimethamine - sulfadoxine arm of this study has been discontinued Patients randomized to this arm will be continued in this study on the original randomized therapy Management of these patients will follow that described for SMXTMP in the latest protocol version AMENDED Lower dose of AZT allowed
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 |
|---|---|---|---|
| 10997 | REGISTRY | DAIDS ES Registry Number | None |