A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002432
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1990
  Purpose

To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of foscarnet maintenance therapy for treatment of AIDS patients experiencing CMV retinitis.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Foscarnet sodium

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Open Study of Foscarnet Treatment of CMV-Retinitis in AIDS Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Prior Medication:

Allowed:

  • Ganciclovir (DHPG).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
  • Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
  • Known allergy to foscarnet.

Concurrent Medication:

Excluded:

  • Nephrotoxic drugs.
  • Acyclovir.

Patients with the following are excluded:

  • Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
  • Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
  • Known allergy to foscarnet.

Prior Medication:

Excluded within 7 days of study entry:

  • Immunomodulators.
  • Biologic response modifiers.
  • Investigational agents (other than ganciclovir).

Patients with AIDS as defined by the CDC, with manifest first episode cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.

  • Patients must be able to give informed consent.
  • Patients who enter the study because of ganciclovir toxicity will have received ganciclovir therapy which resulted in either absolute neutrophil count falling to < 750 cells/mm3 or platelet count falling to < 50000 platelets/mm3 on two separate occasions during either:
  • A ganciclovir induction regimen of 7.5 mg (or more)/kg/day in divided doses.
  • A maintenance regimen of 5 mg (or more)/kg/day as a single daily dose.
  • Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria:
  • CMV retinitis progression has occurred either 1) at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10 mg/kg/day in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 mg (or more)/kg/day, at least 5 days/week) where maintenance therapy began within 1 week of completing induction therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002432

Locations
United States, California
Davies Med Ctr
San Francisco, California, United States, 94114
Sponsors and Collaborators
Astra USA
  More Information

Publications:
Leonard L, Lippe M, Follansbee S, Drennan D, Karol C. An open study of foscarnet treatment of cytomegalovirus (CMV) retinitis in AIDS patients. Int Conf AIDS. 1990 Jun 20-23;6(1):231 (abstract no ThB436)

ClinicalTrials.gov Identifier: NCT00002432     History of Changes
Other Study ID Numbers: 020E, 89-FOS-06
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis
AIDS-Related Opportunistic Infections
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
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
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Foscarnet
Phosphonoacetic Acid
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014