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NCT00000695 · ClinicalTrials.gov registry record · Phase 1
Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00000695: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000695 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000695, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
To determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption. IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.
Interventions
- DRUG Zidovudine
- DRUG Interferon beta-1b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Est. Completion | 1991-07 |
| Phase | Phase 1 |
What the finished NCT00000695 record still lists
NCT00000695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Zidovudine is the first listed.
NCT00000695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000695 about?
NCT00000695 is a clinical study titled "Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma". To determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcut...
What is the current status of trial NCT00000695?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. Estimated completion is 1991-07.
What interventions are being tested in trial NCT00000695?
The interventions under investigation include: Zidovudine (DRUG), Interferon beta-1b (DRUG).
Who is sponsoring clinical trial NCT00000695?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000695's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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