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NCT00000687 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
A Phase 2 study of HIV Infections and Sarcoma, Kaposi, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 9
- Study locations
NCT00000687 is a Phase 2 study of HIV Infections and Sarcoma, Kaposi that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The trial reports 9 study locations across 7 states.
The verdict
NCT00000687, a Phase 2 study of HIV Infections and Sarcoma, Kaposi, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 9
- Study locations
Study Summary
To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Interferon alfa-2a
Study Locations (9)
New York
- Beth Israel Med. Ctr. (Mt. Sinai) - New York
- Univ. of Rochester ACTG CRS - Rochester
Ohio
- Case CRS - Cleveland
- The Ohio State Univ. AIDS CRS - Columbus
Florida
- Univ. of Miami AIDS CRS - Miami
Maryland
- Johns Hopkins Adult AIDS CRS - Baltimore
Massachusetts
- Beth Israel Deaconess - East Campus A0102 CRS - Boston
Missouri
- Washington U CRS - St Louis
Pennsylvania
- Pitt CRS - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Est. Completion | 1993-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000687
The ClinicalTrials.gov registry entry for NCT00000687 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.
NCT00000687 reports 9 study locations spanning 7 distinct geographic areas - top geographies include New York, Ohio, Florida.
Frequently Asked Questions
What is clinical trial NCT00000687 about?
NCT00000687 is a clinical study titled "Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma". To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic ef...
What is the current status of trial NCT00000687?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. Estimated completion is 1993-07.
What conditions does trial NCT00000687 study?
This clinical trial studies the following conditions: HIV Infections, Sarcoma, Kaposi.
What interventions are being tested in trial NCT00000687?
The interventions under investigation include: Zidovudine (DRUG), Interferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00000687?
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 NCT00000687 being conducted?
This trial has 9 study locations across Florida, Maryland, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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