Completed

Safety and Maximum Tolerated Dose of Recombinant Soluble Human CD4 in AIDS and ARC Patients

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What is being tested

CD4 Antigens

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorGenentech, Inc.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on a treatment for patients diagnosed with AIDS or AIDS-related complex (ARC). The treatment in question is recombinant soluble human CD4 (rCD4) therapy. The main goal is to understand the safety of this therapy and to find the highest dose that patients can tolerate without significant side effects. This research is important as it could potentially provide a new treatment option for those living with AIDS or ARC, improving their quality of life and addressing the challenges associated with these conditions. During the study, participants will receive rCD4 therapy through a continuous infusion. The effects of this treatment on the virus will be observed to get a preliminary indication of its antiviral properties. The study will also measure the steady state serum levels of rCD4, which refers to the consistent level of the therapy in the blood after continuous infusion. This will help researchers understand how the body responds to the treatment.

NCT00002005
Principal SponsorGenentech, Inc.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

6 inclusion criteria required to participate
A life expectancy of at least 3 months

A willingness to abstain from all other experimental therapy for HIV infection during the entire study period

Diagnosis of AIDS or AIDS related complex (ARC)

Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy

Show More Criteria

9 exclusion criteria prevent from participating
Malignancies other than Kaposi's sarcoma

Serious active opportunistic infections

Use of chemotherapy within 3 weeks of study entry

Use of corticosteroids

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Genentech Inc

South San Francisco, United StatesOpen Genentech Inc in Google Maps
CompletedOne Study Center