Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000719
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Trial of Alternating 23-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Trial of Alternating 23-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
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 determine the long-term safety and tolerance of four alternating and two intermittent regimens of zidovudine AZT and 23-dideoxycytidine zalcitabine ddC in the treatment of patients with advanced HIV disease who have had to discontinue AZT because of true hematologic intolerance to standard reduced doses of AZT
AIDS is a serious infectious disease caused by a new family of retrovirus which is spread primarily through sexual contact and administration of blood or blood products Individuals who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS virus agent AZT and ddC have both been tested as antiviral agents and their potentially beneficial effects may be limited by time- and dose-dependent toxicity A combination regimen using shorter courses of AZT and ddC might therefore be able to sustain treatment without producing toxicity In addition since the two drugs exhibit their major toxicity on different organ systems cumulative or additive toxicity would not be expected
AIDS is a serious infectious disease caused by a new family of retrovirus which is spread primarily through sexual contact and administration of blood or blood products Individuals who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS virus agent AZT and ddC have both been tested as antiviral agents and their potentially beneficial effects may be limited by time- and dose-dependent toxicity A combination regimen using shorter courses of AZT and ddC might therefore be able to sustain treatment without producing toxicity In addition since the two drugs exhibit their major toxicity on different organ systems cumulative or additive toxicity would not be expected
Detailed Description:
AIDS is a serious infectious disease caused by a new family of retrovirus which is spread primarily through sexual contact and administration of blood or blood products Individuals who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS virus agent AZT and ddC have both been tested as antiviral agents and their potentially beneficial effects may be limited by time- and dose-dependent toxicity A combination regimen using shorter courses of AZT and ddC might therefore be able to sustain treatment without producing toxicity In addition since the two drugs exhibit their major toxicity on different organ systems cumulative or additive toxicity would not be expected
There are six study regimens Four of these are alternating regimens A 2-week cycle consisting of 1 week of AZT followed by 1 week of ddC and an 8-week cycle consisting of 4 weeks of AZT followed by 4 weeks of ddC All patients on alternating regimens will receive AZT alone at the standard dose orally every 4 hours for either 1 or 4 weeks After the AZT is stopped patients receive ddC orally every 4 hours for either 1 or 4 weeks which completes a treatment cycle One of two doses of ddC is studied in each alternating regimen Both doses must be tested because the optimal dose cannot be inferred from tests that have already been done AZT is administered first in the hope that AZT-mediated reduction of p24 antigen load may reduce the occurrence of acute ddC toxicity Two intermittent regimens are also studied and are included to assess the contribution of each drug in the alternating regimens One program consists of 1 week of AZT followed by 1 week of no drug The other consists of 1 week of ddC followed by 1 week of no drug Drug dosing continues for a total of 48 weeks unless toxicity develops Patients who complete 48 weeks of therapy are followed for 4 additional weeks off therapy Patients removed from study because of toxicity are followed for 4 weeks or until toxicity resolves If study participants complete 48 weeks of therapy and meet criteria for efficacy the study drug regimen may be continued for an additional 32 weeks A 4 week wash-out period off drug will not be required for patients continuing on study AMENDED 092490 Drug dosing will be discontinued as of 113090
There are six study regimens Four of these are alternating regimens A 2-week cycle consisting of 1 week of AZT followed by 1 week of ddC and an 8-week cycle consisting of 4 weeks of AZT followed by 4 weeks of ddC All patients on alternating regimens will receive AZT alone at the standard dose orally every 4 hours for either 1 or 4 weeks After the AZT is stopped patients receive ddC orally every 4 hours for either 1 or 4 weeks which completes a treatment cycle One of two doses of ddC is studied in each alternating regimen Both doses must be tested because the optimal dose cannot be inferred from tests that have already been done AZT is administered first in the hope that AZT-mediated reduction of p24 antigen load may reduce the occurrence of acute ddC toxicity Two intermittent regimens are also studied and are included to assess the contribution of each drug in the alternating regimens One program consists of 1 week of AZT followed by 1 week of no drug The other consists of 1 week of ddC followed by 1 week of no drug Drug dosing continues for a total of 48 weeks unless toxicity develops Patients who complete 48 weeks of therapy are followed for 4 additional weeks off therapy Patients removed from study because of toxicity are followed for 4 weeks or until toxicity resolves If study participants complete 48 weeks of therapy and meet criteria for efficacy the study drug regimen may be continued for an additional 32 weeks A 4 week wash-out period off drug will not be required for patients continuing on study AMENDED 092490 Drug dosing will be discontinued as of 113090
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 |
|---|---|---|---|
| 11024 | REGISTRY | DAIDS ES Registry Number | None |