A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Have Not Had Success With Ganciclovir
Status unconfirmed · Not applicable
Conditions studied: Cytomegalovirus Retinitis, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002301
- Run by
- Astra USA
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Allowed:
- Ganciclovir.
You may not qualify if…
- 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.
Where it is running
- Foscarnet Research Program / Park Plaza Hosp — Houston, Texas, United States
Full record on ClinicalTrials.gov
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