Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000770
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Comparative Study of a Combination of Zidovudine Didanosine and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Comparative Study of a Combination of Zidovudine Didanosine and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
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 toxicity of zidovudine AZTdidanosine ddI versus AZTddI combined with nevirapine in HIV-infected patients and to obtain preliminary anti-HIV activity data using immunologic and virologic markers
Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine a non-nucleoside reverse transcriptase inhibitor Thus convergent combination therapy with these three drugs in HIV-infected patients may prove more effective
Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine a non-nucleoside reverse transcriptase inhibitor Thus convergent combination therapy with these three drugs in HIV-infected patients may prove more effective
Detailed Description:
Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine a non-nucleoside reverse transcriptase inhibitor Thus convergent combination therapy with these three drugs in HIV-infected patients may prove more effective
Patients are randomized to receive AZTddI plus either nevirapine or placebo daily for 48 weeks with possible extension for at least 12 weeks At eight participating sites ACTG 808 and 809 will be conducted as virologic and pharmacokinetic substudies
Patients are randomized to receive AZTddI plus either nevirapine or placebo daily for 48 weeks with possible extension for at least 12 weeks At eight participating sites ACTG 808 and 809 will be conducted as virologic and pharmacokinetic substudies
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 |
|---|---|---|---|
| 11218 | REGISTRY | DAIDS ES Registry Number | None |