Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001067
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine 3TC Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600mm3 and No Previous Nucleoside Experience
Status:
COMPLETED
Status Verified Date:
2021-10
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 determine drug efficacy and safety in HIV-infected patients treated with zidovudine AZT versus stavudine d4T versus both drugs Also to compare short- and long-term changes in magnitude of HIV RNA over time
Asymptomatic patients with CD4 counts over 300 cellsmm3 are more likely to tolerate any of the nucleoside analogs d4T with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies provides an additional therapeutic option
Asymptomatic patients with CD4 counts over 300 cellsmm3 are more likely to tolerate any of the nucleoside analogs d4T with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies provides an additional therapeutic option
Detailed Description:
Asymptomatic patients with CD4 counts over 300 cellsmm3 are more likely to tolerate any of the nucleoside analogs d4T with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies provides an additional therapeutic option
Patients are randomized to receive d4T alone AZT alone or both in combination for at least 12 weeks After week 12 3TC is added to the combination arm Treatment continues for up to 48 weeks was a total of 48 weeks amended 32696
Patients are randomized to receive d4T alone AZT alone or both in combination for at least 12 weeks After week 12 3TC is added to the combination arm Treatment continues for up to 48 weeks was a total of 48 weeks amended 32696
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 |
|---|---|---|---|
| 11274 | REGISTRY | DAIDS ES Registry Number | None |