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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 8 participants
Est. Completion 1996-03
Phase Phase 1

What the finished NCT00001105 record still lists

NCT00001105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which F105 Monoclonal Antibody (Human) is the first listed.

NCT00001105 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00001105's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 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

Source: ClinicalTrials.gov NCT00001105, the US trial registry maintained by the National Library of Medicine. NCT00001105 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.