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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: | NCT00000851 |
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden.
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Stavudine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine |
Estimated Enrollment: | 198 |
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Eligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI.
Ages Eligible for Study: | 6 Months to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must:
Prior Medication: Required:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded:
Study Chair: | Kline M | |
Study Chair: | Van Dyke R |
Study ID Numbers: | ACTG 327 |
Study First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000851 |
Health Authority: | United States: Federal Government |
Didanosine Drug Therapy, Combination Antiviral Agents Stavudine |
Virus Diseases Sexually Transmitted Diseases, Viral Stavudine Didanosine HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents 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 |