Ignite Creation Date:
2024-05-05 @ 1:16 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000693
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
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 study the use of acyclovir ACV and zidovudine AZT in the treatment of cytomegalovirus CMV retinitis in patients with AIDS who would otherwise be treated with ganciclovir DHPG alone
CMV retinitis is one of the most common opportunistic infections in patients with AIDS DHPG is at present the only drug available for widespread compassionate use in the United States Although most patients respond to treatment with DHPG the medication does not cure the infection Most patients will have a relapse and will require retreatment with DHPG Because of the large relapse rate most people treated for CMV retinitis are placed on continuous treatment with DHPG There are two major problems associated with ongoing use of DHPG 1 The development of a low white blood cell WBC count leukopenia which is a known side effect of the drug and 2 the increased risk for leukopenia when DHPG is given together with AZT the only antiviral drug currently available for the treatment of HIV infection Therefore patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is made much more severe when the drugs are given together This has resulted in the difficult decision as to whether to forgo potential life-extending therapy with AZT in order to preserve sight An effective treatment for CMV retinitis is needed that will allow the patient to also take AZT ACV is presently the drug of choice for severe herpes virus infections It has been shown to be effective in suppressing severe CMV disease in patients who have received bone marrow transplants
CMV retinitis is one of the most common opportunistic infections in patients with AIDS DHPG is at present the only drug available for widespread compassionate use in the United States Although most patients respond to treatment with DHPG the medication does not cure the infection Most patients will have a relapse and will require retreatment with DHPG Because of the large relapse rate most people treated for CMV retinitis are placed on continuous treatment with DHPG There are two major problems associated with ongoing use of DHPG 1 The development of a low white blood cell WBC count leukopenia which is a known side effect of the drug and 2 the increased risk for leukopenia when DHPG is given together with AZT the only antiviral drug currently available for the treatment of HIV infection Therefore patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is made much more severe when the drugs are given together This has resulted in the difficult decision as to whether to forgo potential life-extending therapy with AZT in order to preserve sight An effective treatment for CMV retinitis is needed that will allow the patient to also take AZT ACV is presently the drug of choice for severe herpes virus infections It has been shown to be effective in suppressing severe CMV disease in patients who have received bone marrow transplants
Detailed Description:
CMV retinitis is one of the most common opportunistic infections in patients with AIDS DHPG is at present the only drug available for widespread compassionate use in the United States Although most patients respond to treatment with DHPG the medication does not cure the infection Most patients will have a relapse and will require retreatment with DHPG Because of the large relapse rate most people treated for CMV retinitis are placed on continuous treatment with DHPG There are two major problems associated with ongoing use of DHPG 1 The development of a low white blood cell WBC count leukopenia which is a known side effect of the drug and 2 the increased risk for leukopenia when DHPG is given together with AZT the only antiviral drug currently available for the treatment of HIV infection Therefore patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is made much more severe when the drugs are given together This has resulted in the difficult decision as to whether to forgo potential life-extending therapy with AZT in order to preserve sight An effective treatment for CMV retinitis is needed that will allow the patient to also take AZT ACV is presently the drug of choice for severe herpes virus infections It has been shown to be effective in suppressing severe CMV disease in patients who have received bone marrow transplants
Patients receive ACV intravenously and AZT orally for 12 weeks Tolerance of the combined administration of ACV and AZT is monitored AMENDED AZT dose lowered and inclusion of concurrent medication expanded
Patients receive ACV intravenously and AZT orally for 12 weeks Tolerance of the combined administration of ACV and AZT is monitored AMENDED AZT dose lowered and inclusion of concurrent medication expanded
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 |
|---|---|---|---|
| 11044 | REGISTRY | DAIDS ES Registry Number | None |