Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002063
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Treatment of AIDS and AIDS Related Complex Part-1- Treatment of Patients With ARC AZT Vs Placebo
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Treatment of AIDS and AIDS Related Complex Part-1- Treatment of Patients With ARC AZT Vs Placebo
Status:
COMPLETED
Status Verified Date:
1990-01
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:
Primary To determine the clinical effect of zidovudine AZT compared to placebo in terms of time to progression to AIDS ie occurrence of major opportunistic infections dementia and malignancies or death Initial drug assignment will be changed to open-label AZT for patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200 cellsmm3 but analysis will be based on initial treatment assignment To determine the immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte concentration of at least 25 percent from baseline assessment To determine the antiviral effect of AZT compared to placebo in eradicating or suppressing HIV Secondary To determine the effect of AZT compared to placebo on the immune status of HIV-infected patients by comparing lymphocyte profiles and indices To determine the long-term toxicities of AZT compared to placebo in terms of abnormalities in BL hepatic function renal function skin gastrointestinal system and central nervous system To describe the natural history of AIDS related complex ARC in placebo patients in terms of initial CD4 lymphocyte concentration and the Walter Reed staging system
Detailed Description:
None
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 |
|---|---|---|---|
| VA Study 298 | None | None | None |