Ignite Creation Date:
2024-05-05 @ 10:30 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01125228
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2010-05-15
Brief Title:
Effectiveness of Zidovudine vs Zidovudine Plus Alpha Interferon vs Interferon for Treatment of HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Study With Long-Term Follow-Up of Zidovudine Versus Zidovudine and Alpha-Interferon Versus Alpha-Interferon in Patients With Early HIV Infection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10-01
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:
This study will compare the effectiveness of zidovudine AZT alone vs zidovudine plus interferon IFN vs interferon alone in reducing HIV viral load lessening immune system deterioration and increasing the time to development of the first opportunistic infection in HIV-infected patients
HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500mm3 or more and no current opportunistic infections may be eligible for this study Candidates will be screened with a medical history physical examination blood tests chest X-ray electrocardiogram urinalysis and for patients with Kaposi s sarcoma lesions measurement photographs and biopsy of lesions
Patients will be assigned to receive treatment with either zidovudine alone zidovudine plus interferon or interferon alone They will continue treatment until one of the following occurs
Unacceptable side effects despite dose modifications
Development of an opportunistic infection
Decrease in CD4 count by 20 percent or to an absolute count of less than 200mm3
Rapid progression of Kaposi s sarcoma lesions requiring alternative therapy
A decision is made to terminate the study
Patients will be followed long term for viral load immune function development of opportunistic infections disease progression and survival
HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500mm3 or more and no current opportunistic infections may be eligible for this study Candidates will be screened with a medical history physical examination blood tests chest X-ray electrocardiogram urinalysis and for patients with Kaposi s sarcoma lesions measurement photographs and biopsy of lesions
Patients will be assigned to receive treatment with either zidovudine alone zidovudine plus interferon or interferon alone They will continue treatment until one of the following occurs
Unacceptable side effects despite dose modifications
Development of an opportunistic infection
Decrease in CD4 count by 20 percent or to an absolute count of less than 200mm3
Rapid progression of Kaposi s sarcoma lesions requiring alternative therapy
A decision is made to terminate the study
Patients will be followed long term for viral load immune function development of opportunistic infections disease progression and survival
Detailed Description:
Initial Study THREE ARM INTERVENTIONAL STUDY
This randomized controlled phase III protocol initiated in 1988 was the first study to examine intervention with antiretroviral therapy and alpha interferon in patients with HIV infection It evaluated the relative efficacy of zidovudine AZT vs AZT alpha interferon IFN vs IFN in increasing time to first opportunistic infection reducing HIV viremia and lessening immune system deterioration in HIV-infected persons
For the AZT alone arm AZT dosing consisted of the standard regimen of 200 mg q4h Persons on the AZT IFN combination arm received AZT 100 mg q4h with IFN beginning at 1 million units qd escalating up to 25 million units at 2 weeks then in increments of 25 million units every 2 weeks Patients on the IFN-alone arm began therapy at 5 million units qd and escalated in 25 million unit increments every 2 weeks unless escalations were precluded by toxicity Patients who had evidence of HIV infection and a CD4 countgreater than or equal to 500 were randomized to one of the three treatment groups Patients were treated with their assigned medication until intolerable toxicity opportunistic infection or progressive Kaposis sarcoma developed or CD4 count declined to less than 200mm3
Our statistically significant findings during this pre-HAART era study showed that interferon-alpha decreased HIV RNA viral load levels both alone and in combination with AZT
Long-Term Follow-up EXTENSION PHASE NATURAL HISTORY STUDY
Once the intervention phase was completed this protocol entered a long-term follow-up phase and evolved into a longitudinal natural history study As of 2013 this work earned the distinction of following a cohort for 25 years or more It continues to serve as an important source of data regarding the long-term outcomes of patients receiving anti-HIV treatment and to provide information on the long-term consequences of therapy In addition stored blood and cells enable the study of cutting edge research questions such as those related to immune activation with new state-of-the-art laboratory assays
This randomized controlled phase III protocol initiated in 1988 was the first study to examine intervention with antiretroviral therapy and alpha interferon in patients with HIV infection It evaluated the relative efficacy of zidovudine AZT vs AZT alpha interferon IFN vs IFN in increasing time to first opportunistic infection reducing HIV viremia and lessening immune system deterioration in HIV-infected persons
For the AZT alone arm AZT dosing consisted of the standard regimen of 200 mg q4h Persons on the AZT IFN combination arm received AZT 100 mg q4h with IFN beginning at 1 million units qd escalating up to 25 million units at 2 weeks then in increments of 25 million units every 2 weeks Patients on the IFN-alone arm began therapy at 5 million units qd and escalated in 25 million unit increments every 2 weeks unless escalations were precluded by toxicity Patients who had evidence of HIV infection and a CD4 countgreater than or equal to 500 were randomized to one of the three treatment groups Patients were treated with their assigned medication until intolerable toxicity opportunistic infection or progressive Kaposis sarcoma developed or CD4 count declined to less than 200mm3
Our statistically significant findings during this pre-HAART era study showed that interferon-alpha decreased HIV RNA viral load levels both alone and in combination with AZT
Long-Term Follow-up EXTENSION PHASE NATURAL HISTORY STUDY
Once the intervention phase was completed this protocol entered a long-term follow-up phase and evolved into a longitudinal natural history study As of 2013 this work earned the distinction of following a cohort for 25 years or more It continues to serve as an important source of data regarding the long-term outcomes of patients receiving anti-HIV treatment and to provide information on the long-term consequences of therapy In addition stored blood and cells enable the study of cutting edge research questions such as those related to immune activation with new state-of-the-art laboratory assays
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 88-I-0172 | None | None | None |