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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001066 |
To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens.
Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Lamivudine Drug: Zidovudine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children |
Estimated Enrollment: | 740 |
Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.
Ages Eligible for Study: | 3 Months to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
PER AMENDMENT 4/29/96:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Study Chair: | McKinney RE | |
Study Chair: | Johnson GM |
Study ID Numbers: | ACTG 300 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00001066 |
Health Authority: | United States: Federal Government |
Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Zidovudine Lamivudine |
Virus Diseases Sexually Transmitted Diseases, Viral Didanosine HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Lamivudine Zidovudine AIDS-Related Complex 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 |