Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000674
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
1999-11-02
Brief Title:
A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis 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 Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
Status:
COMPLETED
Status Verified Date:
2012-05
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 collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS Toxoplasmic encephalitis encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS If untreated the encephalitis is fatal At present it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult There is some information that high doses of parenteral such as by injection clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS Administration of parenteral clindamycin for prolonged periods of time however is costly requires hospitalization and is inconvenient for the patient There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity
Detailed Description:
Toxoplasmic encephalitis encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS If untreated the encephalitis is fatal At present it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult There is some information that high doses of parenteral such as by injection clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS Administration of parenteral clindamycin for prolonged periods of time however is costly requires hospitalization and is inconvenient for the patient There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity
Amended Projected accrual increased to 50 patients Original design Patients receive study medications for a total of 6 weeks unless there are intervening events that require the discontinuation of study therapy Patients are initially treated in the hospital minimum of 7 days Patients who are considered responders at day 7 may complete therapy on an outpatient basis Nonresponders at day 7 may also be managed on an outpatient basis when it is medically appropriate
Amended Projected accrual increased to 50 patients Original design Patients receive study medications for a total of 6 weeks unless there are intervening events that require the discontinuation of study therapy Patients are initially treated in the hospital minimum of 7 days Patients who are considered responders at day 7 may complete therapy on an outpatient basis Nonresponders at day 7 may also be managed on an outpatient basis when it is medically appropriate
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 |
|---|---|---|---|
| 11052 | REGISTRY | None | None |
| ACTG 077 PILOT | Registry Identifier | DAIDS ES Registry Number | None |