Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Triangle Pharmaceuticals
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
