Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000823
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various ZidovudineDidanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various ZidovudineDidanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
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 relative antiviral activity and safety of zidovudine AZT and didanosine ddI alone and in combination as well as in various sequences of administration
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear thus a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear thus a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity
Detailed Description:
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear thus a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity
Patients undergo observation for 2 weeks then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks followed by 4 weeks of post-treatment evaluation The regimens are ddI alone for 32 weeks AZT for 16 weeks followed by ddI for 16 weeks AZT for 16 weeks followed by AZTddI combination for 16 weeks ddI for 16 weeks followed by AZT for 16 weeks AZTddI combination for 32 weeks and placebo for 32 weeks
PER AMENDMENT 61896 NOTE Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up
Patients undergo observation for 2 weeks then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks followed by 4 weeks of post-treatment evaluation The regimens are ddI alone for 32 weeks AZT for 16 weeks followed by ddI for 16 weeks AZT for 16 weeks followed by AZTddI combination for 16 weeks ddI for 16 weeks followed by AZT for 16 weeks AZTddI combination for 32 weeks and placebo for 32 weeks
PER AMENDMENT 61896 NOTE Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11252 | REGISTRY | DAIDS ES Registry Number | None |