Completed

A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)

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What is being tested

AS-101

Drug
Who is being recruted

HIV Infections

From 18 to 60 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

To determine the toxic effects of AS-101 at various doses in patients with AIDS or AIDS related complex. Also to determine the effect of various doses of AS-101 on immune functions and the occurrence of infections in these patients. 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. 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.

Official TitleA Phase One Study of AS-101 in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC) 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
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.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
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.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

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 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
Suspended
Mount Sinai Med CtrNew York, United StatesSee the location

CompletedOne Study Center