Search / Trial NCT00000970

A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Retinitis Aids Related Opportunistic Infections Ganciclovir Drug Evaluation Drug Therapy, Combination Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome

Description

Sight-threatening CMV retinitis occurs in at least 6 percent of AIDS patients. By 1991 (US), there may be 6000 to 10000 patients with CMV retinitis. Many clinical reports suggest that both ganciclovir (DHPG) and foscarnet have an antiviral effect against CMV that is often associated with clinical stabilization. Effectiveness of ganciclovir and foscarnet is correlated with weekly maintenance and since toxicity is dose-limiting in up to 20 percent of patients receiving either drug for long periods, it may be beneficial in long-term maintenance treatment to combine or alternate these two drugs...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Chemotherapy for Kaposi's sarcoma (excluding interferon) if patient is hematologically stable for at least 30 days prior to entry.
  • Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC) after first two weeks of study period if absolute neutrophil count is > 1000 cells/mm3 and hemoglobin = or > 8 g/dl.
  • Vancomycin.
  • Fluconazole or investigational triazoles (e.g., itraconazole, SCH 39304) for disseminated fungal infection.
  • Pneumocystis carinii pneumonia prophylaxis (except parenteral pentamidine).
  • Acyclovir or other appropriate medication may be instituted in the event of the appearance of Herpes simplex virus
  • (HSV) or Varicella zoster virus (VZV) infections.
  • G-CSF or GM-CSF for grade 4 neutropenia.
  • Concurrent Treatment:
  • Allowed:
  • Recombinant human erythropoietin.
  • Prior Medication: Required:
  • Completion of 14-day course of intravenous ganciclovir induction therapy (2.5 mg/kg IV q8h or 5 mg/kg q12h for 14 days) or foscarnet induction therapy (60 mg/kg q8h adjusted for renal function for 14 days) within 1 week prior to study entry. Patients who do not initiate the study immediately upon completing ganciclovir induction therapy should receive a maintenance ganciclovir regimen of 5 mg/kg/day or 6 mg/kg/day 5 x week or a foscarnet regimen of 90-120 mg/kg/day until initiating study drug.
  • Patients must:
  • Have a diagnosis of cytomegalovirus retinitis and HIV infection.
  • Be capable of giving informed consent. Patients < 18 years of age may participate with the consent of parent, guardian, or person with power of attorney.
  • Allowed:
  • History of seizure disorder or a central nervous system (CNS) mass lesion.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Evidence of tuberculous, diabetic or hypertensive retinopathy.
  • Osteomalacia, neoplasm metastatic to bone or other bone disease.
  • Any clinically significant pulmonary or neurologic impairment (for example, patients who are intubated or comatose).
  • Retinal detachment.
  • Corneal, lens, or vitreous opacification precluding funduscopic exam.
  • Concurrent Medication:
  • Excluded:
  • Immunomodulators, biologic response modifiers or investigational agents not specifically allowed.
  • Aminoglycosides, amphotericin B, probenecid, parenteral pentamidine.
  • Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC) until completion of second week of maintenance therapy. ddC use is discouraged but not prohibited because of paucity of experience of this drug with ganciclovir and foscarnet.
  • Anti-cytomegalovirus (CMV) therapy:
  • Ganciclovir, CMV hyperimmune serum/globulin, interferons, immunomodulators.
  • Prophylactic antiviral therapy with acyclovir.
  • Patients with the following are excluded:
  • Active AIDS-defining opportunistic infection requiring therapy that is currently causing nephrotoxicity or myelosuppression.
  • Known hypersensitivity to either of the study therapies.
  • Prior Medication:
  • Excluded:
  • Foscarnet or ganciclovir for CMV retinitis (excluding the 14-day induction period).
  • Prior Treatment:
  • Excluded:
  • Cytomegalovirus (CMV) hyperimmune globulin within 14 days prior to study entry.

Attachments

readout_NCT00000970_2023-12-10.pdf

4.5 MB

NCT00000970_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

San Francisco, California, United States

Saint Louis, Missouri, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
3 stars
2
2 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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