Completed
Recombinant Human CD4 Immunoglobulin G for HIV-Associated Immune Thrombocytopenic Purpura
What is being tested
CD4-IgG
Drug
Who is being recruted
Blood-Borne Infections+28
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+20 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorGenentech, Inc.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This clinical trial focuses on evaluating the effectiveness of a treatment called recombinant human CD4 Immunoglobulin G (CD4-IgG) in managing HIV-associated immune thrombocytopenic purpura. This condition is a disorder where the immune system destroys platelets, which are blood cells responsible for clotting. The study is designed for patients with all levels of HIV infection. The importance of this study lies in its potential to find a new treatment method for this specific complication associated with HIV, which could significantly improve patient care and quality of life.
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 DiseasesCytopeniaAutoimmune DiseasesBlood Coagulation DisordersBlood Platelet DisordersCommunicable DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhageHemorrhagic DisordersImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPathologic ProcessesPurpuraPurpura, ThrombocytopenicRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsSkin ManifestationsPathological Conditions, Signs and SymptomsThrombocytopeniaVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsThrombotic MicroangiopathiesHIV InfectionsPurpura, Thrombocytopenic, Idiopathic
Criteria
10 inclusion criteria required to participate
Zidovudine (AZT) at a constant dose for the 12 weeks of treatment, except if AZT-related toxicity is observed.
Dapsone at a constant dose level and only as a prophylaxis for Pneumocystis carinii pneumonia (PCP).
Dapsone at a constant dose for more than 2 weeks prior to study entry.
Zidovudine at a constant dose for 4 weeks prior to study entry.
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10 exclusion criteria prevent from participating
Ganciclovir (DHPG). Pyrimethamine. Clindamycin. Sulfadiazine. Folinic acid. Prednisone. Intravenous gamma globulin. Intravenous acyclovir. Interferon. Systemic corticosteroids. Non-steroidal anti-inflammatory drugs (NSAIDs). Known immunomodulatory agents. Dideoxycytosine. Dideoxyinosine. Nucleoside analogs (with the exception of zidovudine or topical acyclovir). Any experimental therapy.
Chemotherapy. Immunomodulatory agents. Any experimental therapy. Radiation therapy. Any experimental therapy.
Tumor-associated edema.
Conditions requiring excluded concomitant medications.
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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
CompletedOne Study Center