HIV Infections
Conditions
Keywords
Didanosine, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors
Brief summary
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.
Detailed description
Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).
Interventions
DRUGStavudine
DRUGDidanosine
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed