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A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Have Not Had Success With Ganciclovir

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections

Intervention: Foscarnet sodium (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Astra USA

Summary

To evaluate the safety and efficacy of foscarnet induction treatment of cytomegalovirus (CMV) retinitis in AIDS patients who have previously suffered severe dose-limiting ganciclovir-related myelosuppression, who are ineligible for ganciclovir treatment due to myelosuppression or who have clearly failed to have a therapeutic response to ganciclovir therapy. To assess the duration of clinical response. To evaluate the effect on quantitative CMV cultures of blood and urine. To determine the effect on recovery of HIV p24 antigen capture direct from plasma.

Clinical Details

Official title: Foscarnet Treatment of Cytomegalovirus (CMV) Retinitis in AIDS Patients Not Eligible for Ganciclovir Therapy and Ganciclovir Treatment Failures

Study design: Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria Concurrent Medication: Allowed:

- Ganciclovir.

Exclusion Criteria Co-existing Condition: Patients with the following are excluded:

- Known allergy to foscarnet.

- 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 in

patients with cytomegalovirus (CMV) retinitis. Concurrent Medication: Excluded:

- Acyclovir.

- Nephrotoxic agent.

Patients with the following are excluded:

- Known allergy to foscarnet.

- 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 in

patients with CMV retinitis. Prior Medication: Excluded within 7 days of study entry:

- Immunomodulators.

- Biologic response modifiers.

- Investigational agents.

AIDS patients experiencing cytomegalovirus (CMV) retinitis may be enrolled if they meet one of the following criteria:

- Myelosuppression:

- Previously suffered severe dose-limiting ganciclovir-related myelosuppression, or are

ineligible for ganciclovir treatment due to myelosuppression.

- Ganciclovir treatment failure:

- Clearly failed to have a therapeutic response to ganciclovir therapy.

- Patients must be able to give informed consent.

- Patients presenting with a baseline absolute neutrophil count < 750 cells/mm3 or

baseline platelet count < 50000 platelets/mm3 will be categorized as ineligible to receive ganciclovir induction therapy and will be allowed to enter the study.

- 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 1) a ganciclovir induction regimen of 7. 5 mg or less ganciclovir/kg/day in divided doses or 2) a maintenance regimen of 5 mg or less ganciclovir/kg/day as a single dose.

- Patients who enter the study because of ganciclovir treatment failure will meet one

of the following criteria:

- 1) CMV retinitis progression as defined in section V. C.1., i. e., has occurred either

at the end of a 10 - 21 day induction course of ganciclovir (7. 5 - 10. 0 mg/kg/day in

divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 or more mg/kg/day in at least 5 days/week) where maintenance therapy began within 1. week of completing induction therapy.

Locations and Contacts

Foscarnet Research Program / Park Plaza Hosp, Houston, Texas 77004, United States
Additional Information

Related publications:

Ussery FM, Karol C, Conklin R, Gathe J, Stool E, Redding K. Preliminary results from an on-going prospective evaluation of foscarnet in the treatment of AIDS-associated cytomegalovirus retinitis. Int Conf AIDS. 1989 Jun 4-9;5:551 (abstract no MCP60)


Last updated: June 23, 2005

Page last updated: August 20, 2015

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