A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
NCT ID: NCT00002005
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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CD4 Antigens
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Locations
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Genentech Inc
South San Francisco, California, United States
Countries
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References
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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.
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.
Other Identifiers
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CO036g
Identifier Type: -
Identifier Source: secondary_id
Serial Number 002
Identifier Type: -
Identifier Source: secondary_id
064B
Identifier Type: -
Identifier Source: org_study_id