Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

South San Francisco, California 94080


Purpose:

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).


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.


Study is Available At:


Original ID:

064A


NCT ID:

NCT00002004


Secondary ID:

CO030g


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study,


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:January 1990
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:CD4 Antigens

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Genentech

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.