A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS
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ClinicalTrials.gov Identifier: NCT00000966 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: August 26, 2008
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 2, 1999 | ||||||
First Posted Date ICMJE | August 31, 2001 | ||||||
Last Update Posted Date | August 26, 2008 | ||||||
Study Start Date ICMJE | Not Provided | ||||||
Primary Completion Date | Not Provided | ||||||
Current Primary Outcome Measures ICMJE | Not Provided | ||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||
Change History | Complete list of historical versions of study NCT00000966 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS | ||||||
Official Title ICMJE | A Dose-Escalation, Phase I/II Study of Oral Azithromycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS | ||||||
Brief Summary | To evaluate the effectiveness and toxicity of oral azithromycin and pyrimethamine as acute therapy for toxoplasmic encephalitis in AIDS patients. To assess the toxicity and effectiveness of azithromycin alone as maintenance therapy. Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. Standard treatment for toxoplasmic encephalitis is associated with serious adverse effects. Thus, alternative treatments are needed. |
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Detailed Description | Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. Standard treatment for toxoplasmic encephalitis is associated with serious adverse effects. Thus, alternative treatments are needed. Patients with toxoplasmosis are given azithromycin at doses starting at the lowest dose for the first cohort, an intermediate dose for the second cohort, and a higher dose for the third cohort. Subsequent cohorts may receive azithromycin in increased dosage, if needed to determine the MTD. All patients also receive pyrimethamine. Folinic acid is also provided for as long as patients receive pyrimethamine. Patients are evaluated for clinical response to treatment at days 3, 7, and 14, and weekly for 6 weeks. Maintenance treatment with azithromycin continues for an additional 24 weeks. Patients who complete the study period without relapse or significant toxicity are offered continued therapy by the drug company and are followed for survival and relapse on a monthly basis for 1 year. After the MTD is determined, a subsequent cohort may be added for special studies. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 | ||||||
Study Design ICMJE | Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms | Not Provided | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Enrollment ICMJE |
45 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date | Not Provided | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have the following:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Concurrent Medication: Excluded:
Patients with the following are excluded:
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Sex/Gender |
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Ages | 13 Years and older (Child, Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00000966 | ||||||
Other Study ID Numbers ICMJE | ACTG 156 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
Investigators ICMJE |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
Verification Date | October 1994 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |