Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001057
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
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 Double-Blind Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies Zidovudine Versus Zidovudine in Combination With Didanosine for HIV Infection in Subjects With CD4 Counts 550 Cellsmm3
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 the effects of zidovudine AZT alone and in combination with didanosine ddI on viral load in the lymphoid tissue and blood of antiretroviral-naive HIV-infected patients with CD4 counts greater than or equal to 550 cellsmm3
Recent studies have shown that during the asymptomatic phase clinical latency of HIV infection there is an extraordinarily large number of infected CD4 lymphocytes and macrophages throughout the lymphoid system both in latent and productive states These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period
Recent studies have shown that during the asymptomatic phase clinical latency of HIV infection there is an extraordinarily large number of infected CD4 lymphocytes and macrophages throughout the lymphoid system both in latent and productive states These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period
Detailed Description:
Recent studies have shown that during the asymptomatic phase clinical latency of HIV infection there is an extraordinarily large number of infected CD4 lymphocytes and macrophages throughout the lymphoid system both in latent and productive states These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period
Patients are randomized to receive AZT alone AZT plus ddI or no therapy placebo daily for 48 weeks Patients are followed at weeks 2 4 and 8 and then every 8 weeks thereafter until week 48
Patients are randomized to receive AZT alone AZT plus ddI or no therapy placebo daily for 48 weeks Patients are followed at weeks 2 4 and 8 and then every 8 weeks thereafter until week 48
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 |
|---|---|---|---|
| 11251 | REGISTRY | DAIDS ES Registry Number | None |