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NCT00050856 · ClinicalTrials.gov registry record · Phase 3
Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection
A Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00050856: Completed Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00050856 is a Phase 3 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 5 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00050856, a Phase 3 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once it is already in the cell, Fuzeon prevents the virus from getting into healthy cells. Patients 18 years of age and older with advanced HIV-1 infection, who do not respond to approved antiretroviral therapy, may be eligible for this study. Candidates must have a CD4 lymphocyte count less than 100 cells/mm3 and a viral load greater than 10,000 copies/mL. They will be screened with a medical history, physical examination, and blood tests, and may also have an electrocardiogram (ECG), chest x-ray and urine test. Patients enrolled in the study will be re-examined and have additional blood tests before beginning treatment with Fuzeon. They will then be taught how to self-inject the medicine under the skin and will take two doses daily (less than 1/4 teaspoon each), 12 hours apart. After the first treatment, participants will have follow-up visits at weeks 1, 2, 4, 8, 12, 24, 36, 48, and every 12 weeks after that, if necessary, until 12 weeks after the drug becomes commercially available. Visits may be scheduled more often if a problem arises. During the follow-up visits, patients will have blood drawn, and their blood pressure, pulse rate and temperature will be checked. They will also report any drug side effects they have experienced. Patients may continue to take Fuzeon as long as they benefit from therapy and do not experience severe side effects from the treatment. The drug will be provided to participants until 12 weeks after it is sold in the United States.
Conditions Studied
Interventions
- DRUG Enfuvirtide T/20/Ro 29,9800, HIV-1 Infusion Inhibitor
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2002-11 |
| Est. Completion | 2003-11 |
| Phase | Phase 3 |
What the finished NCT00050856 record still lists
NCT00050856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (99% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Enfuvirtide T/20/Ro 29,9800, HIV-1 Infusion Inhibitor is the first listed.
NCT00050856 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00050856 about?
NCT00050856 is a clinical study titled "Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection". This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once it is already in the c...
What is the current status of trial NCT00050856?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2002-11. Estimated completion is 2003-11.
What conditions does trial NCT00050856 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00050856?
The interventions under investigation include: Enfuvirtide T/20/Ro 29,9800, HIV-1 Infusion Inhibitor (DRUG).
Who is sponsoring clinical trial NCT00050856?
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 NCT00050856 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00050856's enrollment target sits among peer trials
5 540th of 542 higher than 3 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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