Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
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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.
Condition | Intervention | Phase |
---|---|---|
Toxoplasmosis, Cerebral HIV Infections |
Drug: Pyrimethamine Drug: Leucovorin calcium |
Phase 2 |
Study Type: | Interventional |
Study Design: | Masking: Double-Blind Primary Purpose: Prevention |
Official Title: | Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients |
Estimated Enrollment: | 150 |
Study Completion Date: | May 1994 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Show 24 Study Locations
Study Chair: | BJ Luft | |
Study Chair: | JL Vilde |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000643 History of Changes |
Other Study ID Numbers: | ACTG 154, 11129 |
Study First Received: | November 2, 1999 |
Last Updated: | March 29, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Toxoplasmosis Pyrimethamine Leucovorin Drug Evaluation |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Brain Diseases |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Toxoplasmosis Toxoplasmosis, Cerebral Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Coccidiosis Protozoan Infections |
Parasitic Diseases Brain Abscess Abscess Suppuration Infection Central Nervous System Protozoal Infections Central Nervous System Parasitic Infections Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Leucovorin Levoleucovorin Pyrimethamine Vitamin B Complex |
ClinicalTrials.gov processed this record on March 10, 2013