Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000656
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase III Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2 3-Dideoxyinosine Didanosine in Patients With Asymptomatic 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 Phase III Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2 3-Dideoxyinosine Didanosine in Patients With Asymptomatic 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 assess the safety and to evaluate the anti-HIV effect of low- moderate- and high-dose schedules of zidovudine AZT plus didanosine ddI versus ddI alone in asymptomatic HIV-infected patients Because of the failure with long-term more than 1 year use of frequency of toxicity from and drug resistance to AZT drug combinations need to be developed to enable lower less toxic doses of AZT to be used and to slow or prevent the development of resistance while providing at least the same effectiveness
Detailed Description:
Because of the failure with long-term more than 1 year use of frequency of toxicity from and drug resistance to AZT drug combinations need to be developed to enable lower less toxic doses of AZT to be used and to slow or prevent the development of resistance while providing at least the same effectiveness
Enrollment during the first 8 weeks of the study is restricted to hemophiliacs and sexual partners of hemophiliacs with asymptomatic HIV disease After the initial 8 weeks this restriction is lifted Patients are randomized to one of four treatment arms with dosing of AZT plus ddI or ddI alone
Enrollment during the first 8 weeks of the study is restricted to hemophiliacs and sexual partners of hemophiliacs with asymptomatic HIV disease After the initial 8 weeks this restriction is lifted Patients are randomized to one of four treatment arms with dosing of AZT plus ddI or ddI alone
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 |
|---|---|---|---|
| 11118 | REGISTRY | DAIDS ES Registry Number | None |