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The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms Clinical research trials and The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms health trials occur in hundreds of cities throughout 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms. The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms clinical trial. Participants oftentimes recieve the most expert healthcare available for their The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms  The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms
The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and usefulness of zidovudine (AZT) for the treatment of children 3 months to 12 years of age. This study is designed to determine if children who are infected with HIV and who have a special type of lung disease called lymphocytic interstitial pneumonitis (LIP) or other early symptoms of HIV infection may derive benefit from treatment with AZT. It is hoped that this drug will prevent children from developing additional symptoms and infections and will help resolve already existing symptoms. AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy.
Details: AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy. Children who participate in the study are evaluated at a hospital outpatient clinic and are under the care of a specialist in pediatrics. Of the children who participate in the study, half receive AZT syrup and half receive a placebo (sugar solution). The investigator does not know which medication each child receives as this is decided by a random process. The children take the medication in a strawberry-flavored clear syrup every 6 hours (4 times a day), for a period of 2 years or 104 weeks. The children are monitored on an outpatient basis while receiving therapy and the tests performed on admission to the study are repeated several times during treatment. Blood samples are obtained once a week for the first 4 weeks, every other week for the next 4 weeks, and then monthly until the end of the study. At certain sites, Cerebrospinal fluid (CSF) is collected by lumbar puncture every 52 weeks to evaluate infection involving the brain and nervous system. An independent committee reviews the data collected on the children every 6 months. The drug is stopped or the dose reduced if unacceptable side effects develop. AMENDED: As of August 7, 1989 the study blind was broken, the placebo arm discontinued and the study closed to accrual as of September 25, 1989. The 6 children enrolled in the study have been offered AZT.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Prophylaxis for Pneumocystis carinii pneumonia (PCP) in children with AIDS or CD4 cell count = or < 500 cells/mm3. Children must demonstrate the following clinical and laboratory findings: - Laboratory evidence of HIV infection as demonstrated by either a positive viral culture or detectable serum p24 antigen or = or > two positive tests for HIV antibody, which must be determined by a federally licensed ELISA test and confirmed by Western blot. - Children < 15 months of age, who are thought to have acquired HIV through perinatal transmission and whose only laboratory evidence of HIV infection is a positive antibody test, must also have one or more of the following laboratory criteria indicative of immunologic abnormality: - hypergammaglobulinemia (IgG or IgA) defined as greater than the upper limit of normal for age-adjusted normals; absolute depression in the CD4+ cells to = or < 500 cells/mm3; decreased helper/suppressor ratio < 1.0; depressed in vitro mitogen response to at least one antigen/mitogen. - Absence of serious bacterial infections as defined in Exclusion Criteria requiring therapy at the time of entry. - Hemophiliacs are included. Exclusion Criteria Co-existing Condition: Children will be excluded for the following reasons: - Recurrent or life-threatening toxicity. Several allergic reactions such as exfoliative erythroderma, anaphylaxis, or vascular collapse. The presence of one or more of the indicator diseases of AIDS, such as opportunistic infections, malignancy, recurrent bacterial infections, or encephalopathy. Development of two or more episodes of recurrent varicella zoster infection or chronic zoster defined as = or > 30 days duration. Development of AIDS related complex, with failure to thrive, persistent or recurrent oral candidiasis, plus at least one of the following: - Diarrhea that is either persistent or recurrent, lymphadenopathy at two or more noncontiguous sites, organomegaly, nephropathy manifested by nephrotic syndrome without evidence of renal failure, two or more episodes of herpes stomatitis or one or more episodes of herpes zoster within a 1 year period; plus at least one of the following: - hypergammaglobulinemia, depression in the CD4+ cells to = or < 500/mm3, decreased helper/suppressor ratio < 1.0, depressed in vitro mitogen response to at least one antigen/mitogen. Concurrent Medication: Excluded: - Hepatotoxic drugs. - Steroids for lymphocytic interstitial pneumonitis (LIP). - Prophylaxis for oral candidiasis, or otitis media. - Immunoglobulin therapy. - Chronic use of drugs that are metabolized by hepatic glucuronidation. Concurrent Treatment: Excluded: - Supplemental oxygen treatment for lymphocytic interstitial pneumonitis (LIP). Children will be excluded from the study for the following reasons: - AIDS-defining opportunistic infection or neoplasm. - Unexplained recurrent, serious bacterial infections (= or > 2 within a 2-year period) including sepsis, meningitis, pneumonia, abscess of an internal organ, and bone/joint infections caused by Haemophilus, Streptococcus, or other pyogenic bacteria. - Encephalopathy. - One or both of the following: - Failure to thrive, defined as a child who crosses two percentile lines on the growth chart or a child who is less than the fifth percentile and does not follow the curve; and/or persistent (= or > 2 months) oral candidiasis despite appropriate topical therapy. - Children with lymphocytic interstitial pneumonitis (LIP) who are steroid dependent or requiring supplemental oxygen or who have a pretreatment PaO2 < 70 mmHg. - Children who qualify for the entrance criteria to open-label zidovudine (AZT) or AZT plus or minus gammaglobulin. Prior Medication: Excluded: - Rifampin or rifampin derivatives. - Antiretroviral agents. - Zidovudine (AZT). - Excluded within 2 weeks of study entry: - Other experimental therapy. - Drugs which cause prolonged neutropenia or significant nephrotoxicity. - Excluded within 4 weeks of study entry: - Immunomodulating agents including immunoglobulin, interferon, isoprinosine, and IL-2. Prior Treatment: Excluded within 4 weeks of study entry: - Lymphocyte transfusions. Active alcohol or drug abuse.
Total Enrollment: 224
Location and Contact Information:
Overall Study Official:
PWeintrub, Study Chair,
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
UCSD Treatment Ctr
San Diego, California, 92103
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Kaiser Permanente / UCLA Med Ctr
Downey, California, 902422814
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Northern California Pediatric AIDS Treatment Ctr / UCSF
San Francisco, California, 94143
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Martin Luther King Jr Gen Hosp / UCLA Med Ctr
Los Angeles, California, 900593019
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Stanford Univ School of Medicine
Menlo Park, California, 94025
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Columbia Univ Babies' Hosp
New York City, New York, 10032
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: ACTG 052;
Study Start Date:
Record last reviewed: May 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000990
Other Hiv Infections Studies:
1. Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)
2. Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients
3. A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
4. A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3
5. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies
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The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms
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