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Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients Clinical research trials and Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients. Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients clinical trial. Participants typically obtain the most effective healthcare available for their Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients  Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
For Condition: Toxoplasmosis, Cerebral,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the effectiveness of pyrimethamine (given with leucovorin calcium versus placebo (an inactive substance) for the primary prophylaxis (prevention) of cerebral toxoplasmosis in HIV-infected patients. Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent. Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients.
Details: Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent. Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients. AMENDED: 04-04-91 On the first day of therapy, a loading dose is given. After the first day, patients take pyrimethamine or placebo 3 times a week. Patients also take leucovorin calcium orally three times weekly. Enrollment occurs over approximately 12 months. All patients are followed on study until a common study close-out date and final analysis of the study. It is anticipated that this common close-out will occur when the mean duration of time on study therapy will be 3 years (approximately in January, 1994). ORIGINAL design: On the first day of treatment, patients receive a loading dose of pyrimethamine or placebo, plus of leucovorin calcium. After the first day, patients take pyrimethamine or placebo three times a week. Patients also take folinic acid orally three times weekly. The mean duration of study participation is 3 years.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), erythropoietin (Eprex), other agents granted Treatment IND or expanded access status. - Investigational triazoles. - Pentamidine for primary prophylaxis of Pneumocystis carinii pneumonia (PCP). Patients with the following are excluded: - History of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue. - Focal neural abnormalities (except peripheral neuropathy) or mass lesions on a previous computerized tomography (CT) scan or magnetic resonance image (MRI), unless subsequent workup rules out toxoplasmosis, in which case abnormalities must have been stable for at least 2 months. - Known or suspected allergy or severe intolerance to study drugs. Patients must have: - Positive toxoplasma serology. - HIV infection. - Willingness and ability to comply with the protocol and capability of giving written informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Current diagnosis of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue. - Known or suspected allergy or severe intolerance to study drugs. Concurrent Medication: Excluded: - Anticoagulants. Other antifolates, sulfonamides, fansidar, macrolides, 5-fluorouracil, dapsone, or any other agent with known activity against Toxoplasma gondii.
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
BJLuft, Study Chair,
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Nassau County Med Ctr
East Meadow, New York, 11554
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: ACTG 154;
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000643
Other Toxoplasmosis, Cerebral Studies:
1. A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex
2. A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients
3. Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment
4. A Placebo-Controlled, Phase I, Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3, a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 in Individuals With HIV Infection (Placebo patients receive MF59 emulsion only)
5. A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
Related Studies:
Other Toxoplasmosis, Cerebral Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
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