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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CD4 Antigens

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Recombinant Proteins, Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Genentech Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002004

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00002004

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 1990

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Recombinant Proteins, Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CD4 Antigens

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Facility Information:

Facility Name

Genentech Inc

City

South San Francisco

State/Province

California

ZIP/Postal Code

94080

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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