|
A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS Clinical research trials and A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS. A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS clinical trial. Human subjects often get the best healthcare possible for their A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS  A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
For Condition: Toxoplasmosis, Cerebral,HIV Infections
Status: Completed
Sponsor(s): Upjohn , National Institute of Allergy and Infectious Diseases (NIAID),Glaxo Wellcome
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Erythropoietin. - Aerosolized pentamidine for prophylaxis against Pneumocystis carinii pneumonia (PCP). - Immunoglobulin therapy. - Alpha interferon. - Patients entering study on isoniazid (INH) may continue INH therapy. - Use of corticosteroids is discouraged. If corticosteroids are needed for the management of intracranial hypertension or cranial mass effect, use of dexamethasone is encouraged (4 g orally 4 times daily for 3 days and thereafter tapered over the next 10 to 14 days). Patients are admitted into the study if they have: - Laboratory evidence of HIV infection or if they have an undetermined HIV infection status if they belong to a high-risk group for HIV infection. - Either a definite or presumptive diagnosis of toxoplasmic encephalitis. Patient or appropriate family member, or legal designee must be able to understand and sign a written informed consent. Allowed: - HIV encephalopathy. AMENDED: - Allows patients who have relapsed. Patients with a previous diagnosis of toxoplasmic encephalitis based on histopathology or documented neuroradiological response to pyrimethamine and sulfonamides or pyrimethamine and clindamycin and who have relapsed toxoplasmic encephalitis. Relapse must be documented by definite progression of lesions or appearance of new lesions compatible with toxoplasmic encephalitis. Prior Medication: Allowed if liver enzymes stable for 6 weeks prior to study entry: - Rifampin. - Isoniazid. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Infections of the central nervous system. - Malabsorption syndrome (3 or more loose stools a day for at least 4 weeks associated with an unintentional weight loss of at least 10 percent of body weight). - History of sensitivity to the study medication. - Malignancies requiring the use of cytotoxic chemotherapy. - Coma. - Diffuse central white matter lesions. - Negative serology for Toxoplasma as performed at the Palo Alto Medical Foundation (unless biopsy is positive). - Lymphoma of the central nervous system. - Cerebral Kaposi's sarcoma. - Hemorrhagic diathesis or active bleeding disorder. Concurrent Medication: Excluded: - Erythromycin or other macrolides. - Sulfonamides. - Immunomodulators. - Cytotoxic chemotherapy. - Amphotericin. - Dapsone. - Rifamycins. - Ganciclovir. - Allopurinol. - Antifolates. - Azidothymidine and other antiretrovirals and investigational agents not specifically allowed. - Folate supplements. - Isoniazid (INH) therapy may not be started while on therapy. Concurrent Treatment: Excluded: - Lymphocyte replacement. Patients with the following are excluded: - Negative HIV antibodies by a federally licensed ELISA (as determined at or after study entry), unless there is documentation of a previously positive HIV culture or p24 antigen. - Coma. - Diffuse central white matter lesions. - Negative serology for Toxoplasma as performed at the Palo Alto Medical Foundation (unless biopsy is positive). - Lymphoma of the central nervous system. - Cerebral Kaposi's sarcoma. - Hemorrhagic diathesis or active bleeding disorder. - Unable to take oral medications reliably. - Any medical or social condition which, in the opinion of the investigator, would adversely affect either participation and/or compliance in this study. Prior Medication: Excluded: - Treatment for toxoplasmic encephalitis.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
RemingtonJS, Study Chair,
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Presbyterian Univ Hosp / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Additional Information:
Study ID Numbers: ACTG 077 PILOT;
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000674
Other Hiv Infections Studies:
1. A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs
2. A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection
3. A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
4. Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination with Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects
5. Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
|
|
|
|
|
|
|
|
