Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000640
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase III Comparative Study of Dapsone Trimethoprim and Clindamycin Primaquine Versus Sulfamethoxazole Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Comparative Study of Dapsone Trimethoprim and Clindamycin Primaquine Versus Trimethoprim Sulfamethoxazole in the Treatment of Mild-to-Moderate PCP in Patients With 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 evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia PCP dapsonetrimethoprim or clindamycinprimaquine as compared to a standard treatment program of sulfamethoxazoletrimethoprim SMXTMP to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMXTMP Per 090992 amendment to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMXTMP
The type of treatment being studied has the advantages of wide applicability throughout the world including developing countries and low cost An oral treatment is more accessible to patients than drugs given by injection or by inhalation
The type of treatment being studied has the advantages of wide applicability throughout the world including developing countries and low cost An oral treatment is more accessible to patients than drugs given by injection or by inhalation
Detailed Description:
The type of treatment being studied has the advantages of wide applicability throughout the world including developing countries and low cost An oral treatment is more accessible to patients than drugs given by injection or by inhalation
Patients with confirmed PCP are randomized into one of three treatment groups Group A receives SMXTMP Half of group A receives dapsone placebo placebo is an inactive substance daily plus trimethoprim placebo the other half receives clindamycin placebo plus primaquine placebo Group B is given dapsone plus trimethoprim Half of group B receives SMXTMP placebo the other half receives clindamycin placebo plus primaquine placebo Group C is given clindamycin plus primaquine Half of group C receives SMXTMP placebo the other half receives dapsone placebo plus trimethoprim placebo Treatment lasts 21 days dosages will be adjusted for patients weighing less than 50 kg and more than 80 kg Patients with a history of intolerance to SMXTMP for whom rechallenge is considered medically contraindicated may be randomized to one of the non-sulfamethoxazole-containing arms
Patients with confirmed PCP are randomized into one of three treatment groups Group A receives SMXTMP Half of group A receives dapsone placebo placebo is an inactive substance daily plus trimethoprim placebo the other half receives clindamycin placebo plus primaquine placebo Group B is given dapsone plus trimethoprim Half of group B receives SMXTMP placebo the other half receives clindamycin placebo plus primaquine placebo Group C is given clindamycin plus primaquine Half of group C receives SMXTMP placebo the other half receives dapsone placebo plus trimethoprim placebo Treatment lasts 21 days dosages will be adjusted for patients weighing less than 50 kg and more than 80 kg Patients with a history of intolerance to SMXTMP for whom rechallenge is considered medically contraindicated may be randomized to one of the non-sulfamethoxazole-containing arms
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 |
|---|---|---|---|
| 11083 | REGISTRY | DAIDS ES Registry Number | None |