Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
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| ClinicalTrials.gov Identifier: NCT00000643 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 2, 2021
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Toxoplasmosis, Cerebral HIV Infections | Drug: Pyrimethamine Drug: Leucovorin calcium | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 150 participants |
| Masking: | Double |
| Primary Purpose: | Prevention |
| Official Title: | Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients |
| Actual Study Completion Date : | May 1994 |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000643
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| Study Chair: | BJ Luft | ||
| Study Chair: | JL Vilde |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000643 |
| Other Study ID Numbers: |
ACTG 154 11129 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 2, 2021 |
| Last Verified: | October 2021 |
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Toxoplasmosis Pyrimethamine Leucovorin Drug Evaluation |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Brain Diseases |
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Toxoplasmosis Toxoplasmosis, Cerebral Infections Coccidiosis Protozoan Infections Parasitic Diseases Brain Abscess Central Nervous System Infections Central Nervous System Protozoal Infections Central Nervous System Parasitic Infections Abscess Suppuration Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Leucovorin Pyrimethamine Calcium Levoleucovorin Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |