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A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus Clinical research trials and A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus. A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus clinical trial. Participants oftentimes recieve the finest healthcare available for their A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus  A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus
A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To prevent individuals who have had a massive accidental exposure to HIV from becoming infected with HIV and possibly developing AIDS, by treating them with zidovudine (AZT). Although the number of persons who have been (or will be) exposed to a high concentration of HIV is quite small, these persons have a high risk of becoming infected and treatments are needed to prevent infection after such an exposure. In animal studies, AZT has prevented the development of infections after exposure of the animals to a retrovirus (the HIV is a retrovirus). In patients with AIDS, AZT has been effective in delaying the progression of the disease. For these reasons a trial of AZT is indicated.
Details: Although the number of persons who have been (or will be) exposed to a high concentration of HIV is quite small, these persons have a high risk of becoming infected and treatments are needed to prevent infection after such an exposure. In animal studies, AZT has prevented the development of infections after exposure of the animals to a retrovirus (the HIV is a retrovirus). In patients with AIDS, AZT has been effective in delaying the progression of the disease. For these reasons a trial of AZT is indicated. Persons accepted into the study will take AZT capsules every 4 hours (6 times daily) for 42 days. Treatment with AZT should start as soon as possible, but no later than 5 days, after exposure to the HIV. Blood and urine samples for various studies will be taken at intervals during the 42-day treatment period, and blood samples will be taken every 3 months for 1 year and every 6 months for 2 years and tested for signs of HIV infection (HIV antibody determinations).
Eligibility:
Study Type: Interventional, Prevention, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Participant must be HIV-negative at entry and source must be HIV-positive. The source should be documented to be infected with HIV by one of the following criteria: - Clinical diagnosis of AIDS or ARC. - Positive test for HIV antibody (both ELISA and Western blot) or presence of HIV p24 antigen in serum. - Participant may be enrolled if the source of exposure is suspected of being infected with HIV (member of risk group, some type of symptom of HIV infection), but the source must be confirmed to be infected with HIV for the participant to remain in the study. - Significant exposure within 5 days prior to beginning therapy, defined as one of the following: - Research laboratory workers or auxiliary personnel who, during the course of their work, were exposed to high titers of virus on abraded skin or mucous membranes or were accidentally inoculated with high titers of cell-associated or free virus through an exposed wound or puncture. - Organ transplant recipients from HIV-positive donor. - Recipients of blood or blood products from HIV-positive donor. - Women who have been artificially inseminated with semen from HIV-positive donor. - Other sources of exposure considered appropriate by the principal investigator and the sponsor. - Persons with poor health (such as renal, hepatic, or bone marrow insufficiency) will be evaluated on a case-by-case basis. Exclusion Criteria Prior Medication: Excluded within 4 weeks of study entry: - Treatment with any potentially myelosuppressive drug. - Nephrotoxic agents. - Other experimental therapy. Prior Treatment: Excluded within 1 month of study entry: - Blood transfusion with evidence of compromised blood marrow function. Patients may not have any of the following: - History of a malignancy other than cutaneous basal cell or cervical carcinomas. - Significant, chronic underlying medical illness which, in the physician's judgment, would impair study completion. - Liver dysfunction with bilirubin > 5 x ULN, alkaline phosphatase > 5 x upper limit of normal, or SGPT > 5 x upper limit of normal. - Compromised bone marrow function with hemoglobin < 11 g/dl or blood transfusion within the last month, granulocytes < 1500 cells/mm3, or platelets < 100000/mm3. When possible, no other concomitant medication will be administered during the treatment period. Prior diagnosis of HIV infection by one of the following criteria: - HIV antibody positive by ELISA or Western blot assays. - HIV p24 antigen positive. - Clinical symptoms which lead to a diagnosis by a licensed physician of AIDS / AIDS related complex (ARC) / AIDS dementia. Active drug or alcohol abuse sufficient in the investigators' opinion to prevent compliance with the study regimen.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PettinelliC, Study Chair,
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
United States
Additional Information:
Study ID Numbers: NS 402;
Study Start Date:
Record last reviewed: April 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000993
Other Hiv Infections Studies:
1. A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
2. Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
3. A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
4. Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals
5. The Treatment of Tuberculosis in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Research Triangle Park Clinical Trials
A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus
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