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.
Patients are randomized to receive either MKC-442 or placebo, along with stavudine(d4T),
didanosine(ddI), and hydroxyurea. Patients will be treated and followed for 48 weeks.
- 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 nucleoside reverse transcriptase and protease inhibitors.
- Cytotoxic chemotherapy more than 30 days prior to entry.
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
- 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.
- Any experimental antiretroviral therapy or immunomodulators directed against HIV-1,
e.g., IL-4, cyclosporine steroids at doses greater than 40 mg/day.
- Non-nucleoside reverse transcriptase inhibitor therapy.
- 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.
Active substance abuse that may interfere with compliance or protocol evaluations.