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OpenTrials
Completed

NCT Number: NCT00002039

An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

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 three different foscarnet maintenance therapy regimens. To determine the pharmacokinetics of intermittent administration of foscarnet with or without concomitant administration of zidovudine (AZT).

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Key information

Conditions

Cytomegalovirus Retinitis AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Cytomegalovirus Infections DNA Virus Infections Eye Diseases Eye Infections Eye Infections, Viral Genital Diseases HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Opportunistic Infections RNA Virus Infections Retinal Diseases Retinitis Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foscarnet Research Program / Park Plaza Hosp

Houston, Texas, 77004, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Recurrent episode of cytomegalovirus (CMV) retinitis.

Concurrent Medication:

Excluded:

  • Nephrotoxic drugs.

Patients with the following are excluded:

  • Recurrent episode of cytomegalovirus (CMV) retinitis.
  • 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:

  • Ganciclovir for cytomegalovirus (CMV) retinitis.
  • Foscarnet for CMV retinitis.

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.

Treatment and study plan

Foscarnet sodium

Drug

Sponsors and collaborators

Lead sponsor

Astra USA

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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