Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005106
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-04-06
Brief Title:
A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A 96-Week Randomized Open-Label Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine 40mg BID Plus Lamivudine 150mg BID Plus Nelfinavir 1250mg BID Versus Abacavir 300mg BID Plus Combivir 3TC 150mgZDV 300mg BID Versus Combivir 3TC 150mgZDV 300mg BID Plus Nelfinavir 1250mg BID in HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2000-11
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:
The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before
Detailed Description:
Patients are randomized to receive stavudine plus lamivudine plus nelfinavir Combivir zidovudine plus lamivudine plus nelfinavir or Combivir plus abacavir Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA 1 greater than 1000 up to 100000 copiesml or 2 greater than 100000 up to 200000 copiesml Measurements and evaluations for assessment of body fat composition virologic and immunologic outcomes markers of alterations in carbohydrate and lipid metabolism and safety are performed at Baseline Weeks 4 8 16 24 and every 12 weeks thereafter until Week 96 or withdrawal In addition health-related quality of life and health care resource utilization data are collected at specified treatment visits
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 |
|---|---|---|---|
| ESS40002 | None | None | None |