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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000716 |
To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24 weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating HIV infection in infants and children will also be evaluated.
HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children. AZT has been shown to be effective in certain adult patients with symptomatic HIV infection. It is therefore likely that infected children may also benefit from this treatment.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Zidovudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection |
Estimated Enrollment: | 70 |
HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children. AZT has been shown to be effective in certain adult patients with symptomatic HIV infection. It is therefore likely that infected children may also benefit from this treatment.
The participants receive AZT mixed with juice at a dose dependent on body size every 6 hours for 24 weeks. The children are evaluated weekly for the first 4 weeks, every two weeks for the subsequent 8 weeks, and monthly thereafter. Blood samples are collected periodically and cerebrospinal fluid (CSF) by lumbar puncture on 2 occasions.
Ages Eligible for Study: | 3 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must comply with the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following will be excluded:
Concurrent Medication:
Concomitant medications should be kept to a minimum.
Excluded:
Children with lymphocytic interstitial pneumonitis (LIP) as their only clinical sign of HIV infection will be excluded from the study. Children with any of the following laboratory findings within 2 weeks of entry will be excluded:
Prior Medication:
Excluded within 2 weeks of study entry:
Prior Treatment:
Excluded within 4 weeks of study entry:
Active alcohol or drug abuse.
United States, California | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
Johns Hopkins Hosp - Pediatric | |
Baltimore, Maryland, United States, 212874933 | |
United States, Massachusetts | |
Children's Hosp of Boston | |
Boston, Massachusetts, United States, 021155724 | |
United States, New Jersey | |
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
Newark, New Jersey, United States, 071072198 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Wilfert C |
Study ID Numbers: | ACTG 043, NCI-T88-0191N, Protocol 26,341--08, Project P53, FDA 9C |
Study First Received: | November 2, 1999 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00000716 |
Health Authority: | United States: Federal Government |
Drug Evaluation Administration, Oral Acquired Immunodeficiency Syndrome Zidovudine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |