The purpose of this study is to see if it is safe and effective to give MKC-442 plus
stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria
Concurrent Medication:
Allowed:
- Based on medical history, medical condition, prior use of antiretroviral drugs, and
genotypic analysis of the predominant strain of HIV-1 isolated from the plasma,
administration of a combination of two or more available antiretroviral agents by
prescription may be given with MKC-442.
Patient must have:
- HIV infection with HIV-1 RNA greater than or equal to 5,000 by Roche Amplicor method
within 30 days of entry.
- A failed protease inhibitor-containing regimen.
- Negative serum beta human chorionic gonadotropin test within 30 days of entry.
Prior Medication:
Allowed:
- Prior nucleoside reverse transcriptase and protease inhibitors.
- Cytotoxic chemotherapy more than 30 days prior to entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability
to consume adequate oral intake because of chronic nausea, emesis, or abdominal or
esophageal discomfort.
- Inadequately controlled seizure disorder.
- Known intolerance to stavudine, didanosine, and/or hydroxyurea.
- Acute and clinically significant medical event within 30 days of screening.
- Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the
exception of laboratory values given.
Concurrent Treatment:
Excluded:
- Any experimental antiretroviral therapy or immunomodulators directed against HIV-1,
e. g., IL-4, cyclosporine steroids at doses greater than 40 mg/day.
Prior Medication:
Excluded:
- Non-nucleoside reverse transcriptase inhibitor therapy.
Prior Treatment:
Excluded:
- Radiation therapy within 30 days of entry except to a local lesion.
- Transfusion of blood or blood products within 21 days of screening.
- Cytotoxic therapy within 3 months of study entry.
Risk Behavior:
Excluded:
Active substance abuse that may interfere with compliance or protocol evaluations.