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NCT00002004 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002004
Other study ID # 064A
Secondary ID CO030gSerial Num
Status Completed
Phase Phase 1
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date January 1990
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CD4 Antigens

Locations
Country Name City State
United States Genentech Inc South San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

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