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A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC) Clinical research trials and A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC) health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC). A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC) Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC) clinical trial. Test subjects typically receive the most expert healthcare available for their A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC) condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC)  A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC)
A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC)
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
SacksHS, Study Chair,
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Additional Information:
Study ID Numbers: ACTG 046;
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001006
Other Hiv Infections Studies:
1. Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
2. Use of Muscle Spectroscopy to Evaluate Mitochondrial Dysfunction in HIV-Infected Patients
3. Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
4. Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
5. A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
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A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC)
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