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| Descriptive Information Fields | |||||||||
| Brief Title † | A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children | ||||||||
| 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 | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Double-Blind, Safety Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections | ||||||||
| Intervention † | Drug: Lamivudine Drug: Zidovudine Drug: Didanosine |
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| MEDLINE PMIDs | 11364606, 11364462, 11176565, 14571184 | ||||||||
| Links | Click here for more information about Zidovudine  Click here for more information about Didanosine Click here for more information about Lamivudine |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 740 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | 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:
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| Gender | Both | ||||||||
| Ages | 3 Months to 15 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States, Puerto Rico | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00001066 | ||||||||
| Organization ID | ACTG 300 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators †† | Bristol-Myers Squibb Glaxo Wellcome |
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| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | November 1998 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | August 25, 2008 | ||||||||
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