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NCT00001105 · ClinicalTrials.gov registry record · Phase 1
The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00001105 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 8 participants.
The verdict
NCT00001105, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
To determine the safety and pharmacokinetics of F105 human monoclonal antibody both following a single dose and during intermittent administration in HIV-infected patients. To determine specific dose concentrations sufficient to achieve efficacy and avoid toxicity. To determine the effect of F105 on virologic, immunologic, and serologic parameters. Early in the course of HIV infection, the primary humoral immune response appears to be highly strain specific and to be directed at a hypervariable portion of the viral gp120. The F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown to neutralize the IIIB, SF2, and MN strains of HIV at concentrations readily achievable in humans.
Interventions
- DRUG F105 Monoclonal Antibody (Human)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Est. Completion | 1996-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001105
The ClinicalTrials.gov registry entry for NCT00001105 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which F105 Monoclonal Antibody (Human) is the first listed.
NCT00001105 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001105 about?
NCT00001105 is a clinical study titled "The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV". To determine the safety and pharmacokinetics of F105 human monoclonal antibody both following a single dose and during intermittent administration in HIV-infected patients. To determine specific dose concentrations sufficient to achieve efficacy and avoid toxicity. To determine the effect of F105 on...
What is the current status of trial NCT00001105?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. Estimated completion is 1996-03.
What interventions are being tested in trial NCT00001105?
The interventions under investigation include: F105 Monoclonal Antibody (Human) (DRUG).
Who is sponsoring clinical trial NCT00001105?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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