- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001006
A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)
A Phase One Study of AS-101 in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
Study Overview
Detailed Description
AIDS is a viral disease that is characterized by a loss of some immune function and the development of frequent, eventually fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs. AS-101 is a synthetic organic compound containing the metal tellurium that is being tested because in laboratory studies it improved immune functions.
Patients are given intravenous infusions of AS-101 3 times a week for 12 weeks. The first group of 6 patients receives a dose that did not cause toxic effects in a preliminary study. If no adverse effects occur, the next 6 patients receive a higher dose level and so on, until an optimum dose has been reached. The investigators will determine the optimum dose based on the type and severity of adverse effects experienced by the patients on the study and by the effect of the drug on the immune function of the patient and its effect on the HIV infection. Samples of blood and urine are taken periodically during the study and skin tests are performed 3 times to aid in the evaluation of AS-101. Patients receive standard treatment for any infections that develop during the study.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Ketoconazole.
- Standard outpatient therapy for infections developing during the trial.
- Oral acyclovir for up to 7 days.
Patients must have:
- Antibody to HIV by ELISA.
- AIDS or AIDS related complex (ARC).
- T4 cell count < 400 cells/mm3 on 2 determinations at least 72 hours apart.
Prior Medication:
Allowed:
- Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Ketoconazole.
- Oral acyclovir for up to 7 days.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Active opportunistic infection or malignancy requiring concurrent treatment.
- Serious medical problems, such as diabetes, renal disease, ASHD, or hypertension, which would complicate interpretation of treatment results.
- Transfusion requirements exceeding 2 transfusions per month in order to achieve hemoglobin > 9 g/dl.
Concurrent Medication:
Excluded:
- Treatment for active opportunistic infection or malignancy.
- Systemic antiviral preparations.
- Immunosuppressive agents.
- Immunostimulation therapy.
- Specific therapy for Kaposi's sarcoma or other malignancies.
Concurrent Treatment:
Excluded:
- More than 2 units of red blood cell transfusions per month in order to achieve hemoglobin > 8 g/dl.
Patients unlikely or unable, for reasons such as distance from the hospital or psychological considerations, to comply with the requirements of the protocol, especially in regard to regular attendance for treatment, are excluded.
Prior Medication:
Excluded:
- Systemic antiviral preparations.
- Isoprinosine.
- Excluded with 1 month of study entry:
- Immunosuppressive agents.
- Immunomodulators.
Prior Treatment:
Excluded:
- Immunostimulation therapy, such as BCG vaccine.
Active drug or alcohol abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Sacks HS
- Study Chair: Hassett J
Publications and helpful links
General Publications
- Lewi DS, Acceturi CA, Diaz RS, Lofty C, Sader H. AS 101: tolerability, safety and clinical efficacy in HIV positive patients with advanced disease. Int Conf AIDS. 1992 Jul 19-24;8(3):100 (abstract no PuB 7310)
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- AIDS-Related Complex
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Radiation-Protective Agents
- Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Other Study ID Numbers
- ACTG 046
- 11020 (DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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