A Study of MKC-442 in Combination With Other Anti-HIV Drugs

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002412

Run by

Triangle Pharmaceuticals

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.
• 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.

Where it is running

• Dr Robert Wallace — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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