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A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) Clinical research trials and A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC). A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)  A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)
A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body. The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children.
Details: The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children. Patients are hospitalized for 8 weeks to receive AZT through the intravenous (IV) route at 1 of 2 doses. Patients are then discharged from hospital and take AZT by mouth for 4 more weeks.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Treatment: Allowed: - Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements). Exclusion Criteria Co-existing Condition: Children with the following conditions are excluded: - Asymptomatic with T-lymphocyte deficiency. - Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS. - Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study. - Hemoglobinopathy including sickle cell anemia. - Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth. Children with the following conditions are excluded: - Asymptomatic with T-lymphocyte deficiency. - Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS. - Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study. - Hemoglobinopathy including sickle cell anemia. - Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth. Prior Medication: Excluded: - Suramin. - Ribavirin. - HPA 23. - Phosphonoformate. - Ansamycin. - Interleukin 2. - Interferon. - Excluded within 30 days of study entry: - All cytolytic chemotherapeutic agents, immunomodulating agents including steroids and immunoglobulin preparations. - Antivirals (acyclovir, ganciclovir). Prior Treatment: Excluded within 4 weeks of study entry: - Lymphocyte transfusions for immune reconstitution. - Excluded within 3 months of study entry: - Bone marrow transplant. Child who is seropositive for HIV antibody or has HIV viremia and presents with one or more of following clinical criteria and at least one of the laboratory criteria may be considered an ARC patient for purpose of study: - Clinical criteria: - Persistent oral candidiasis despite appropriate therapy. - Wasting syndrome characterized by failure to thrive and malnutrition. - Recurrent or chronic unexplained diarrhea. - Lymphadenopathy (more than 1 cm) at 2 or more noncontiguous sites. - Hepatomegaly with or without splenomegaly. - Encephalopathy with loss of developmental milestones and cortical atrophy present on computed tomography (CT) examination. - Recurrent bacterial infections (bacteremia, pneumonia, septic arthritis, meningitis). - Cutaneous anergy as defined by lack of delayed cutaneous hypersensitivity to selected antigens. - Laboratory criteria: - Hypergammaglobulinemia (IgG or IgA) defined as immunoglobulin values exceeding the maximum age-adjusted level. - Decreased number of total T-lymphocytes (2 SD from mean). - Absolute depression in T-helper cells to less than 500/mm3. - Depressed (equal to or more than 2 SD from normal mean) in vitro mitogen response to at least one antigen. - One positive HIV culture within 3 months of study entry into the study or blood obtained and culture pending. - Life expectancy greater than 6 months. - Ambulatory and free of opportunistic infection at time of entry. - Reliably diagnosed disease at least moderately indicative of underlying cellular immunodeficiency and no known cause of underlying cellular immunodeficiency or other reduced resistance reported to be associated with that disease. - Disease accepted as sufficiently indicative of underlying cellular immunodeficiency by CDC. In absence of these opportunistic diseases, a histologically confirmed diagnosis of chronic lymphoid interstitial pneumonitis will be considered indicative of AIDS unless test(s) for HIV are negative.
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
ScottG, Study Chair,
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Additional Information:
Study ID Numbers: ACTG 003; Protocol 26,541-004,Project p53
Study Start Date:
Record last reviewed: December 1988
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000701
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4. Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
5. Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected with HIV
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A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)
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