A Randomized, Double-Blind Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination With Twice-Daily Dosing of Stavudine in HIV-Infected Subjects

Study start date: February 1, 2004

Inclusion Criteria Patients must have: Documented HIV infection. CD4 cell count of at least 100 cells/mm3. Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment. Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening. Inability to tolerate oral medication. Any other clinical condition that would preclude compliance with dosing requirements. 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. 1. Potent neurotoxic drugs, such as vincristine and thalidomide. Other anti-HIV therapy. 1. Prophylaxis for pneumocystis carinii pneumonia (PCP) is strongly recommended for patients with CD4 cell counts less than or equal to 200/mm3 or who have had a prior episode of PCP. Immunizations recommended by ACIP for routine practice. Erythropoietin and G-CSF are allowed if myelosuppression emerges on study. 1. Any antiretroviral therapy. Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry. 1. Any prior antiretroviral therapy. 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.