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A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cerebral Toxoplasmosis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Concurrent Medication:

Allowed:

- Aerosolized pentamidine for prophylaxis against Pneumocystis carinii pneumonia (PCP).

- Allowed during maintenance period (weeks 7 - 24):

- Zidovudine and other antiretrovirals available through treatment IND mechanisms,
ganciclovir, and maintenance doses of amphotericin (other investigational therapies
require permission from the study chair), steroids for the treatment of acute PCP.

- Isoniazid (INH) only for patients already on INH.

Patients must have the following:

- HIV infection or belong to high-risk group. Presumptive or definite diagnosis of
toxoplasmic encephalitis.

- Each patient, or his/her appropriate family member, or legal designee must be able to
understand and sign a written informed consent, in accordance with the local practices
at each site.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- History of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or
tissue.

- Coma.

- More than 72 hours of treatment for current episode of toxoplasmic encephalitis prior
to study entry.

- Central nervous system (CNS) lymphoma.

- Cerebral Kaposi's sarcoma.

- Active hepatitis or clinical jaundice.

- History of serious hypersensitivity or intolerance to any of the study drugs.

- Serum or cerebrospinal fluid (CSF) positive for cryptococcus antigen or culture.

- Malignancies requiring use of cytotoxic chemotherapy.

- Inability to take oral therapy reliably.

- Malabsorption syndrome.

Concurrent Medication:

Excluded:

- Opportunistic infection requiring either acute treatment or maintenance therapy with
azithromycin, erythromycin or other macrolides, sulfonamides, amphotericin, dapsone,
ganciclovir, antifolates, and other investigational agents except erythropoietin. For
first 6 weeks of treatment, patients may not receive treatment with erythromycin (or
other macrolides), sulfonamides, immunomodulators with the exception of alpha
interferon, lymphocyte replacement, cytotoxic chemotherapy, dapsone, ganciclovir,
rifampicin, coumadin, antiretrovirals, and investigational agents other than
erythropoietin.

Patients with the following are excluded:

- Negative HIV antibodies by a federally licensed ELISA, unless there is documentation
of a previously positive HIV culture or p24 antigen.

- Infections of the central nervous system.

- Malignancies requiring the use of cytotoxic chemotherapy.

- Any medical or social condition that, in the opinion of the investigator, would
adversely affect participation and/or compliance in this study.

NCT00000966
Pfizer
Completed
A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS

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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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Toxoplasmosis, Cerebral
  • HIV Infections
Intervention  ICMJE
  • Drug: Azithromycin
  • Drug: Pyrimethamine
  • Drug: Leucovorin calcium
Study Arms  ICMJE Not Provided
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
45
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Aerosolized pentamidine for prophylaxis against Pneumocystis carinii pneumonia (PCP).
  • Allowed during maintenance period (weeks 7 - 24):
  • Zidovudine and other antiretrovirals available through treatment IND mechanisms, ganciclovir, and maintenance doses of amphotericin (other investigational therapies require permission from the study chair), steroids for the treatment of acute PCP.
  • Isoniazid (INH) only for patients already on INH.

Patients must have the following:

  • HIV infection or belong to high-risk group. Presumptive or definite diagnosis of toxoplasmic encephalitis.
  • Each patient, or his/her appropriate family member, or legal designee must be able to understand and sign a written informed consent, in accordance with the local practices at each site.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • History of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue.
  • Coma.
  • More than 72 hours of treatment for current episode of toxoplasmic encephalitis prior to study entry.
  • Central nervous system (CNS) lymphoma.
  • Cerebral Kaposi's sarcoma.
  • Active hepatitis or clinical jaundice.
  • History of serious hypersensitivity or intolerance to any of the study drugs.
  • Serum or cerebrospinal fluid (CSF) positive for cryptococcus antigen or culture.
  • Malignancies requiring use of cytotoxic chemotherapy.
  • Inability to take oral therapy reliably.
  • Malabsorption syndrome.

Concurrent Medication:

Excluded:

  • Opportunistic infection requiring either acute treatment or maintenance therapy with azithromycin, erythromycin or other macrolides, sulfonamides, amphotericin, dapsone, ganciclovir, antifolates, and other investigational agents except erythropoietin. For first 6 weeks of treatment, patients may not receive treatment with erythromycin (or other macrolides), sulfonamides, immunomodulators with the exception of alpha interferon, lymphocyte replacement, cytotoxic chemotherapy, dapsone, ganciclovir, rifampicin, coumadin, antiretrovirals, and investigational agents other than erythropoietin.

Patients with the following are excluded:

  • Negative HIV antibodies by a federally licensed ELISA, unless there is documentation of a previously positive HIV culture or p24 antigen.
  • Infections of the central nervous system.
  • Malignancies requiring the use of cytotoxic chemotherapy.
  • Any medical or social condition that, in the opinion of the investigator, would adversely affect participation and/or compliance in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Study Chair:Luft B
Study Chair:Remington J
PRS AccountNational Institute of Allergy and Infectious Diseases (NIAID)
Verification DateOctober 1994

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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