Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000696
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Phase III Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease
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 anti-HIV effect of single agent versus combination therapy with zidovudine AZT and interferon alfa-2a IFN-A2a as measured by p24 protein expression viral growth and infectivity in patients with symptomatic HIV disease To assess the safety of low dose schedules of AZT and IFN-A2a alone and in combination as measured by neutrophil counts and hepatic transaminase levels To evaluate the comparative effects of single agent versus combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity
AZT is known to be an effective treatment for HIV infection However patients may develop reactions to AZT when it is administered for long periods of time Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone
AZT is known to be an effective treatment for HIV infection However patients may develop reactions to AZT when it is administered for long periods of time Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone
Detailed Description:
AZT is known to be an effective treatment for HIV infection However patients may develop reactions to AZT when it is administered for long periods of time Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone
AMENDED 04-18-91 Treatment extended to 96 weeks Patients are seen weekly for the first month and for the month following initiation of combination therapy Cohorts 1 2 then every other week until treatment week 48 followed by every week for the duration of the study AMENDED The doses have been modified to one of 4 total daily doses of AZT and one of 4 daily doses of IFN-A2a AMENDED Total treatment period will be 48 weeks AMENDED 9-24-90 Treatment will end 901214 Original Design Before beginning any treatment patients are carefully examined and evaluated Each patient receives medication for 24 weeks followed by a 4-week follow-up period Patients are assigned randomly to one of four dosing schedules within one of three groups stratified according to whether or not they have ever received AZT and or IFN-A2a
Group 1 receives AZT alone for 12 weeks then AZT plus IFN-A2a for the following 12 weeks
Group 2 receives IFN-A2a alone for 12 weeks then IFN-A2a plus AZT for the following 12 weeks
Group 3 receives the combination of AZT and IFN-A2a for 24 weeks Medications are administered according to one of four possible daily dosing schedules of AZT plus IFN-A2a increasing doses of each AZT is taken by mouth as a capsule every 6 hours IFN-A2a is given by an injection under the skin once a day Initially doses of IFN-A2a are given by one of the research staff after which patients are taught to give their own injections Patients are examined weekly for the first 4 weeks then every other week until the end of the study Patients assigned to groups receiving two drugs will be examined weekly again for 4 weeks when the second drug is added
AMENDED 04-18-91 Treatment extended to 96 weeks Patients are seen weekly for the first month and for the month following initiation of combination therapy Cohorts 1 2 then every other week until treatment week 48 followed by every week for the duration of the study AMENDED The doses have been modified to one of 4 total daily doses of AZT and one of 4 daily doses of IFN-A2a AMENDED Total treatment period will be 48 weeks AMENDED 9-24-90 Treatment will end 901214 Original Design Before beginning any treatment patients are carefully examined and evaluated Each patient receives medication for 24 weeks followed by a 4-week follow-up period Patients are assigned randomly to one of four dosing schedules within one of three groups stratified according to whether or not they have ever received AZT and or IFN-A2a
Group 1 receives AZT alone for 12 weeks then AZT plus IFN-A2a for the following 12 weeks
Group 2 receives IFN-A2a alone for 12 weeks then IFN-A2a plus AZT for the following 12 weeks
Group 3 receives the combination of AZT and IFN-A2a for 24 weeks Medications are administered according to one of four possible daily dosing schedules of AZT plus IFN-A2a increasing doses of each AZT is taken by mouth as a capsule every 6 hours IFN-A2a is given by an injection under the skin once a day Initially doses of IFN-A2a are given by one of the research staff after which patients are taught to give their own injections Patients are examined weekly for the first 4 weeks then every other week until the end of the study Patients assigned to groups receiving two drugs will be examined weekly again for 4 weeks when the second drug is added
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 |
|---|---|---|---|
| 11042 | REGISTRY | DAIDS ES Registry Number | None |