Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001063
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Study of the Virologic and Immunologic Effects of d4T vs Zidovudine Plus d4T vs Zidovudine Plus Ddl in HIV-Infected Patients With CD4 Cell Counts Between 300-600mm3 and Greater Than 12 Weeks Zidovudine Experience
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 compare the effect of stavudine d4T alone or with zidovudine AZT versus didanosine ddI alone or with AZT on CD4 counts HIV RNA levels and viral load in HIV-infected patients AS PER AMENDMENT 32197 To compare the effects of d4T alone versus ddI alone versus AZT plus ddI To compare the safety of d4TAZT AS PER AMENDMENT 32197 To evaluate the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular level
Although AZT and ddI can delay the advancement of HIV disease the benefit of either of these drugs has proven to be only temporary d4T a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV offers an additional therapeutic option It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression thus this study measures effects on viral load and CD4 count
Although AZT and ddI can delay the advancement of HIV disease the benefit of either of these drugs has proven to be only temporary d4T a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV offers an additional therapeutic option It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression thus this study measures effects on viral load and CD4 count
Detailed Description:
Although AZT and ddI can delay the advancement of HIV disease the benefit of either of these drugs has proven to be only temporary d4T a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV offers an additional therapeutic option It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression thus this study measures effects on viral load and CD4 count
Patients are randomized in a blinded fashion to receive AZT or placebo in combination with open-label d4T or ddI for up to 48 weeks AS PER AMENDMENT 32197 The study is now composed of three arms open-label d4T versus open-label ddI plus blinded AZT placebo versus blinded AZT plus open-label ddI Patients originally assigned to the d4T AZT arm which was closed 1096 will be given the option of discontinuing AZT and remaining on d4T monotherapy or discontinuing all study drugs In addition all study participants will be asked to participate in a pharmacology substudy
Patients are randomized in a blinded fashion to receive AZT or placebo in combination with open-label d4T or ddI for up to 48 weeks AS PER AMENDMENT 32197 The study is now composed of three arms open-label d4T versus open-label ddI plus blinded AZT placebo versus blinded AZT plus open-label ddI Patients originally assigned to the d4T AZT arm which was closed 1096 will be given the option of discontinuing AZT and remaining on d4T monotherapy or discontinuing all study drugs In addition all study participants will be asked to participate in a pharmacology substudy
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 |
|---|---|---|---|
| 11266 | REGISTRY | DAIDS ES Registry Number | None |