Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000765
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4 Lymphocyte Decline in Patients With Primary HIV Infection One Treatment Arm Receives Placebo
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4 Lymphocyte Decline in Patients With Primary HIV Infection One Treatment Arm Receives Placebo
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 evaluate the safety and efficacy of early treatment with zidovudine for preventing a decline in CD4 lymphocyte counts in patients with primary HIV infection To determine the natural history of virologic and immunologic changes in primary HIV infection
Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy
Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy
Detailed Description:
Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy
Patients are randomized to receive either zidovudine or placebo daily for 24 weeks Patients are followed until development of an AIDS-related opportunistic infection or malignancy After week 24 patients meeting standard prescribing criteria may start FDA-approved anti-HIV therapies After study week 48 patients may co-enroll on another clinical trial to receive experimental therapy
Patients are randomized to receive either zidovudine or placebo daily for 24 weeks Patients are followed until development of an AIDS-related opportunistic infection or malignancy After week 24 patients meeting standard prescribing criteria may start FDA-approved anti-HIV therapies After study week 48 patients may co-enroll on another clinical trial to receive experimental therapy
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 |
|---|---|---|---|
| 11733 | REGISTRY | DAIDS ES Registry Number | None |