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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002004
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

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).

Interventions

DRUGCD4 Antigens

Sponsors

Genentech, Inc.
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026