Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000970
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Open-Labeled Study of Long Term Combined or Alternating FoscarnetGanciclovir Maintenance Therapy for AIDS Patients With CMV Retinitis After Ganciclovir Induction Therapy
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To examine the safety and tolerance of the administration of ganciclovir and foscarnet given together or alternately to determine the interactive pharmacokinetics blood level profile of long-term combined and alternating therapy with these two drugs Additional objectives are to examine the effect of these treatments in controlling time to cytomegalovirus CMV retinitis progression and to examine the antiviral activity of combined and alternating ganciclovirfoscarnet treatment and development of antiviral resistance Sight-threatening CMV retinitis occurs in at least 6 percent of AIDS patients By 1991 US there may be 6000 to 10000 patients with CMV retinitis Many clinical reports suggest that both ganciclovir DHPG and foscarnet have an antiviral effect against CMV that is often associated with clinical stabilization Effectiveness of ganciclovir and foscarnet is correlated with weekly maintenance and since toxicity is dose-limiting in up to 20 percent of patients receiving either drug for long periods it may be beneficial in long-term maintenance treatment to combine or alternate these two drugs at a lower total weekly dose of each drug
This strategy may result in a greater net antiviral effect with less toxicity than is seen with either drug alone because the toxicities of each drug are quite different
This strategy may result in a greater net antiviral effect with less toxicity than is seen with either drug alone because the toxicities of each drug are quite different
Detailed Description:
Sight-threatening CMV retinitis occurs in at least 6 percent of AIDS patients By 1991 US there may be 6000 to 10000 patients with CMV retinitis Many clinical reports suggest that both ganciclovir DHPG and foscarnet have an antiviral effect against CMV that is often associated with clinical stabilization Effectiveness of ganciclovir and foscarnet is correlated with weekly maintenance and since toxicity is dose-limiting in up to 20 percent of patients receiving either drug for long periods it may be beneficial in long-term maintenance treatment to combine or alternate these two drugs at a lower total weekly dose of each drug
This strategy may result in a greater net antiviral effect with less toxicity than is seen with either drug alone because the toxicities of each drug are quite different
All patients have newly diagnosed CMV retinitis and have completed a 14-day course of intravenous ganciclovir or foscarnet induction therapy within 1 week prior to study entry The maintenance period consists of a 12-week study period followed by a 40 week follow-up period Treatment consists of either combined sequential daily maintenance therapy of both foscarnet and ganciclovir or alternating daily treatment with ganciclovir one day and foscarnet the following day
This strategy may result in a greater net antiviral effect with less toxicity than is seen with either drug alone because the toxicities of each drug are quite different
All patients have newly diagnosed CMV retinitis and have completed a 14-day course of intravenous ganciclovir or foscarnet induction therapy within 1 week prior to study entry The maintenance period consists of a 12-week study period followed by a 40 week follow-up period Treatment consists of either combined sequential daily maintenance therapy of both foscarnet and ganciclovir or alternating daily treatment with ganciclovir one day and foscarnet the following day
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11126 | REGISTRY | DAIDS ES Registry Number | None |