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CompletedNCT00002005Updated Jun 24, 2005

A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex

An interventional study of CD4 Antigens in HIV Infections, sponsored by Genentech, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Genentech, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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 obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To measure steady state serum levels of rCD4 following continuous infusion therapy.

02

Conditions studied

  • HIV Infections

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Keywords

  • Acquired Immunodeficiency Syndrome
  • Antigens, CD4
  • AIDS-Related Complex
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria

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:

  • Zidovudine (AZT).
  • Chemotherapy.
  • Immunomodulators.
  • Other experimental therapy.
04

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

  • DrugCD4 Antigens
05

Study locations

1 site
  • Genentech Inc
    South San Francisco, California 94080, United States
06

References and documents

Publications

  • Arranz R, Garcia-Noblejas A, Grande C, Cannata-Ortiz J, Sanchez JJ, Garcia-Marco JA, Alaez C, Perez-Calvo J, Martinez-Sanchez P, Sanchez-Gonzalez B, Canales MA, Conde E, Martin A, Arranz E, Terol MJ, Salar A, Caballero D. First-line treatment with rituximab-hyperCVAD alternating with rituximab-methotrexate-cytarabine and followed by consolidation with 90Y-ibritumomab-tiuxetan in patients with mantle cell lymphoma. Results of a multicenter, phase 2 pilot trial from the GELTAMO group. Haematologica. 2013 Oct;98(10):1563-70. doi: 10.3324/haematol.2013.088377. Epub 2013 Jun 10. PubMed 23753021 ↗
  • Picado A, Singh SP, Rijal S, Sundar S, Ostyn B, Chappuis F, Uranw S, Gidwani K, Khanal B, Rai M, Paudel IS, Das ML, Kumar R, Srivastava P, Dujardin JC, Vanlerberghe V, Andersen EW, Davies CR, Boelaert M. Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial. BMJ. 2010 Dec 29;341:c6760. doi: 10.1136/bmj.c6760. PubMed 21190965 ↗
07

Registry details

Key details

Study ID
NCT00002005
Lead sponsor
Genentech, Inc.
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 1990. You cannot join it, but the record below documents what was studied.

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