Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000712
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Multicenter Double Blind Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4 Counts Less Than 200 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Double Blind Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4 Counts Less Than 200 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:
Original design The studys purpose is to compare the effects of zidovudine AZT alone to the combination of AZT and acyclovir ACV to determine if AZTACV is associated with a lower death rate and fewer AIDS related opportunistic infections compared to AZT alone and to investigate the effect of these treatment plans on cytomegalovirus CMV and Epstein-Barr virus EBV infections The study evaluates two doses of AZT used alone versus two doses of AZT combined with ACV Per 121192 amendment Another antiretroviral agent may be substituted for AZT
AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related complex and patients being treated for Pneumocystis carinii pneumonia Drugs that increase the effectiveness of AZT against HIV may also decrease the need for high doses of AZT This might reduce some of the negative effects of AZT while not reducing the positive effects
AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related complex and patients being treated for Pneumocystis carinii pneumonia Drugs that increase the effectiveness of AZT against HIV may also decrease the need for high doses of AZT This might reduce some of the negative effects of AZT while not reducing the positive effects
Detailed Description:
AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related complex and patients being treated for Pneumocystis carinii pneumonia Drugs that increase the effectiveness of AZT against HIV may also decrease the need for high doses of AZT This might reduce some of the negative effects of AZT while not reducing the positive effects
AMENDED Patients are randomly assigned to one of two treatment regimens They receive AZT or other antiretroviral agent with or without ACV Treatment Plan 1 AZT along with placebo at the same time Treatment Plan 2 AZT and ACV Therapy is for 104 weeks with an optional extension of 24 weeks or until the end of the study whichever comes first The maximum duration of therapy for any patient will be 128 weeks Medication is dispensed on a biweekly basis for the first 4 weeks then every other month for the remainder of the study Original design Patients are randomly assigned to one of four treatment plans to receive AZT alone or AZT and ACV Medications are given every 4 hours q4h orally PO while awake WA A total of 5 dosesday are given The per dose schedule for the four plans are Treatment plan 1 AZT plus placebo an inactive medication substituting for ACV Treatment plan 2 AZT and AZT placebo along with an ACV placebo Treatment plan 3 AZT and ACV Treatment plan 4 AZT and AZT placebo and ACV
AMENDED Patients are randomly assigned to one of two treatment regimens They receive AZT or other antiretroviral agent with or without ACV Treatment Plan 1 AZT along with placebo at the same time Treatment Plan 2 AZT and ACV Therapy is for 104 weeks with an optional extension of 24 weeks or until the end of the study whichever comes first The maximum duration of therapy for any patient will be 128 weeks Medication is dispensed on a biweekly basis for the first 4 weeks then every other month for the remainder of the study Original design Patients are randomly assigned to one of four treatment plans to receive AZT alone or AZT and ACV Medications are given every 4 hours q4h orally PO while awake WA A total of 5 dosesday are given The per dose schedule for the four plans are Treatment plan 1 AZT plus placebo an inactive medication substituting for ACV Treatment plan 2 AZT and AZT placebo along with an ACV placebo Treatment plan 3 AZT and ACV Treatment plan 4 AZT and AZT placebo and ACV
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 |
|---|---|---|---|
| 11037 | REGISTRY | DAIDS ES Registry Number | None |