NCT00001105

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

March 1, 1996

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Antibodies, MonoclonalAIDS-Related ComplexImmunization, Passive

Interventions

F105 Monoclonal Antibody (Human)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • PART B ONLY. Allowed:
  • Concomitant AZT or other antiretroviral drugs if patient is on a stable dose of such therapy within 3 months prior to study entry.
  • Patients must have:
  • Documented HIV-1 infection.
  • CD4 count 200 - 500 cells/mm3 (Part A) or \<= 400 cells/mm3 (Part B, per amendment).
  • No diagnosis of AIDS (Part A only, per amendment).
  • Life expectancy of at least 6 months.
  • Part B patients only (per amendment):
  • Primary (viral) isolates sensitive to F105 antibody using the yield reduction assay currently under development by ACTG, determined within 15-90 days prior to study entry.
  • Plasma viremia by qualitative plasma culture.
  • NO active opportunistic infection within 6 weeks prior to drawing of first isolate.
  • NO AIDS-related malignancy other than minimal Kaposi's sarcoma.
  • Prior Medication:
  • Allowed:
  • +1 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Evidence of active renal disease as manifested by sediment containing red or white cell casts.
  • Concurrent Treatment:
  • Excluded:
  • Red cell transfusions administered to maintain hemoglobin at acceptable level or alleviate symptoms of anemia.
  • Prior Medication:
  • Excluded within 6 weeks prior to study entry:
  • Intravenous gamma globulin.
  • Chemotherapy.
  • Corticosteroids.
  • Other experimental therapy.
  • EXCLUDED IN ALL PATIENTS:
  • Immunosuppressive treatments, cytokine therapy, or biologic response modifiers not included in this study, including interferons or adjuvant treatment for chronic and severe fungal infections such as cryptococcal meningitis.
  • Intravenous gamma globulin.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Wolfe EJ, Cavacini LA, Samore MH, Posner MR, Kozial C, Spino C, Trapnell CB, Ketter N, Hammer S, Gambertoglio JG. Pharmacokinetics of F105, a human monoclonal antibody, in persons infected with human immunodeficiency virus type 1. Clin Pharmacol Ther. 1996 Jun;59(6):662-7. doi: 10.1016/S0009-9236(96)90006-5.

    PMID: 8681491BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAIDS-Related Complex

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Samore MH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

March 1, 1996

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(1)