Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000994
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposis Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Placebo-Controlled Trial To Evaluate Azidothymidine AZT in the Treatment of Human Immunodeficiency Virus HIV Infection in Patients With AIDS-Associated Kaposis Sarcoma
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 whether taking zidovudine AZT will change the natural course of HIV infection in patients with AIDS-associated Kaposis sarcoma KS and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent AZT is a drug that is effective in inhibiting the effects of HIV infection The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan and whether AZT therapy will delay the development of opportunistic infections andor KS lesions
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent AZT is a drug that is effective in inhibiting the effects of HIV infection The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan and whether AZT therapy will delay the development of opportunistic infections andor KS lesions
Detailed Description:
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent AZT is a drug that is effective in inhibiting the effects of HIV infection The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan and whether AZT therapy will delay the development of opportunistic infections andor KS lesions
Patients are divided into two treatment groups the first receiving AZT for 5 doses a day and the second receiving AZT for 3 doses per day A placebo group is divided into two to match the two treatment groups Study patients are stratified according to whether they have a 10 or fewer cutaneous lesions without oral lesions or b more extensive cutaneous lesions or oral lesions Patients are seen on an outpatient basis weekly for the first 2 months every other week for the next 2 months and monthly thereafter
Patients are divided into two treatment groups the first receiving AZT for 5 doses a day and the second receiving AZT for 3 doses per day A placebo group is divided into two to match the two treatment groups Study patients are stratified according to whether they have a 10 or fewer cutaneous lesions without oral lesions or b more extensive cutaneous lesions or oral lesions Patients are seen on an outpatient basis weekly for the first 2 months every other week for the next 2 months and monthly thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10977 | REGISTRY | DAIDS ES Registry Number | None |