Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005764
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-05-30
Brief Title:
A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects TARHEEL
Status:
COMPLETED
Status Verified Date:
2001-06
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 see if the findings of increased lactic acid and abnormal fat distribution get better when d4T is replaced with abacavir abacavir plus lamivudine or Combivir a pill containing lamivudine plus zidovudine in HIV-positive patients taking anti-HIV therapy including stavudine d4T
Detailed Description:
Patients are allocated as follows a zidovudine-naive patients switch Combivir for d4t and b zidovudine-experienced or -intolerant patients switch abacavir for d4t Providers may choose between Combivir or abacavir as a switch for d4t when screening lactate levels are 22 mmolL or more Additionally providers may choose to switch a maximum of 2 drugs one of which must be d4t in the regimen Each patient receives 48 weeks of therapy Visits are made at Weeks 2 4 8 12 16 20 24 32 40 and 48 Tests including biopsies are performed to measure changes in body fat distribution and changes in lactate levels Virologic and immunologic outcomes changes in physical signs of lipodystrophy changes in self-reports of health-related quality-of-life survey and the Body Image Questionnaire changes in lipid profile and other markers of metabolism and safety parameters are evaluated also
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 |
|---|---|---|---|
| ESS40010 | None | None | None |