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The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.
Full description
Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).
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Inclusion and exclusion criteria
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Patients with the following prior conditions are excluded:
History of acute or chronic pancreatitis.
Intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry.
Proven or suspected acute hepatitis within 30 days prior to study entry.
Other anti-HIV therapy.
Immunizations recommended by ACIP for routine practice.
Erythropoietin and G-CSF are allowed if myelosuppression emerges on study.
Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.
Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.
Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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