NCT00002004

Brief Summary

To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To assess pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).

Trial Health

80
On Track

Trial Health Score

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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

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

June 24, 2005

Status Verified

January 1, 1990

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Recombinant ProteinsAcquired Immunodeficiency SyndromeAntigens, CD4AIDS-Related Complex

Interventions

CD4 AntigensDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • HIV-1 seropositivity.
  • Diagnosis of AIDS or AIDS related complex (ARC).
  • Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
  • The ability to sign a written informed consent form prior to treatment.
  • A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
  • A life expectancy of at least 3 months.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Serious active opportunistic infections.
  • Malignancies other than Kaposi's sarcoma.
  • Concurrent Medication:
  • Excluded:
  • Zidovudine (AZT).
  • Corticosteroids.
  • Nonsteroidal anti-inflammatory agents (NSAI).
  • Other experimental therapy.
  • Patients with the following are excluded:
  • Serious active opportunistic infections.
  • Malignancies other than Kaposi's sarcoma.
  • Prior Medication:
  • Excluded within 3 weeks of study entry:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genentech Inc

South San Francisco, California, 94080, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

CD4 Antigens

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

Intervention Hierarchy (Ancestors)

Receptors, Interleukin-16Receptors, InterleukinReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, HIVReceptors, VirusAntigens, Differentiation, T-LymphocyteAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkers

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1990-01

Locations

US(1)