Clinical trial NCT00002005: A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
Official title: A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
Antigens, CD4
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: South San Francisco
country: United States
facility: Genentech Inc
state: California
Study officials:
References:
citation: 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.
citation: 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.