Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006397
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-10-10
Brief Title:
Differences Between Women and Men Taking a Combination of Indinavir Ritonavir Enteric-Coated Didanosine and Stavudine Who Previously Took Anti-HIV Drugs
Sponsor:
PPD
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Study of the Combination of Indinavir Ritonavir Enteric-Coated ddI and d4T In Nucleoside and Non-Nucleoside Reverse Transcriptase Inhibitor Experienced Patients An Open-Label Study Investigating Differences Between Women and Men
Status:
UNKNOWN
Status Verified Date:
2001-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir IDV plus ritonavir RTV plus enteric-coated didanosine ddI plus stavudine d4T and if there are differences in responses between men and women
Detailed Description:
Patients are enrolled in balanced numbers based on gender and stratified by viral load less than or equal to 10000 10000 to 100000 or more than 100000 copiesml Prior to therapy a peer-based patient education intervention is presented Patients receive a combination of IDV RTV enteric-coated ddI and d4T Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences A pharmacokinetic sub-study balanced so that half of patients are male and half are female is performed on IDV and RTV for 20 to 25 of the patients About 20 females are examined for study-drug effects on gonadotropic hormone levels
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 |
|---|---|---|---|
| BMS 2000 | None | None | None |