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NCT01125228 · ClinicalTrials.gov registry record
Effectiveness of Zidovudine vs. Zidovudine Plus Alpha Interferon vs. Interferon for Treatment of HIV
A clinical trial of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- 180
- Enrollment target
- 1
- Study location
NCT01125228: Active study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01125228 is a study of HIV that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125228, a study of HIV, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- 180 participants
- Enrollment target
- 1
- Study location
Study 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 500/mm3 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 200/mm3 * 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.
Primary Outcome
long-term follow-up of the medical and treatment outcomes of patients who received anti-HIV treatment and alpha-IFN in the pre-HAART era
Conditions Studied
Interventions
- DRUG Ziodovudine and Alpha Interferon
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 1988-10-19 |
What the registry record for NCT01125228 still lists
NCT01125228 is an observational study that tracks outcomes without assigning an intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (59% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Ziodovudine and Alpha Interferon is the first listed.
NCT01125228 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01125228 about?
NCT01125228 is a clinical study titled "Effectiveness of Zidovudine vs. Zidovudine Plus Alpha Interferon vs. Interferon for Treatment of HIV". 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-...
What is the current status of trial NCT01125228?
This trial is currently active not recruiting. The enrollment target is 180 participants. The study started on 1988-10-19.
What conditions does trial NCT01125228 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01125228?
The interventions under investigation include: Ziodovudine and Alpha Interferon (DRUG).
Who is sponsoring clinical trial NCT01125228?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01125228 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01125228's enrollment target sits among peer trials
180 120th of 303 higher than 182 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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