Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Astra USA


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002432

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1990
History of Changes
Purpose

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

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
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

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

More Information


Responsible Party: Astra USA  
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  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Retinitis
AIDS-Related Opportunistic Infections
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Infection
Cytomegalovirus Retinitis
Retinitis
Foscarnet
Phosphonoacetic Acid

ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.