Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002199
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase III Randomized Double-Blind Multicenter Study to Evaluate the Safety and Efficacy of 3TCZDV1592U89 and 3TCZDVIDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Randomized Double-Blind Multicenter Study to Evaluate the Safety and Efficacy of 3TCZDV1592U89 and 3TCZDVIDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects
Status:
COMPLETED
Status Verified Date:
1998-11
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 safety tolerance early antiviral activity and durability of antiviral response of the lamivudine 3TCzidovudine ZDV1592U89 arm versus the 3TCZDVindinavir IDV arm To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC defined class BC events survival medical resource utilization and the development of plasma viral genotypic and phenotypic resistance
Detailed Description:
In this international study 550 patients are randomized 225 per arm to receive Combivir in combination with 1592U89 or indinavir If after 16 weeks and every 8 weeks thereafter until week 48 a patient has HIV-1 RNA 400 copiesml by PCR on two occasions 1 week and 4 weeks apart the patient has the option to switch to open-label therapy consisting of indinavir 1592U89 and Combivir
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 |
|---|---|---|---|
| CNAAB3005 | None | None | None |