A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS

Not Applicable

Completed

• Conditions: Toxoplasmosis, Cerebral; HIV Infections

• Registration Number: NCT00000674
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study Completion: 1992-08
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-17
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (13)

USC CRS; 🇺🇸 Los Angeles, California, United States

Johns Hopkins Adult AIDS CRS; 🇺🇸 Baltimore, Maryland, United States

Univ. of Miami AIDS CRS; 🇺🇸 Miami, Florida, United States

Ucsd, Avrc Crs; 🇺🇸 San Diego, California, United States

SUNY - Buffalo, Erie County Medical Ctr.; 🇺🇸 Buffalo, New York, United States

Cornell University A2201; 🇺🇸 New York, New York, United States

Memorial Sloan-Kettering Cancer Ctr.; 🇺🇸 New York, New York, United States

Washington U CRS; 🇺🇸 St. Louis, Missouri, United States

NY Univ. HIV/AIDS CRS; 🇺🇸 New York, New York, United States

Duke Univ. Med. Ctr. Adult CRS; 🇺🇸 Durham, North Carolina, United States

Stanford CRS; 🇺🇸 Palo Alto, California, United States

Pitt CRS; 🇺🇸 Pittsburgh, Pennsylvania, United States

Unc Aids Crs; 🇺🇸 Chapel Hill, North Carolina, United States