A Study of MKC-442 in Combination With Other Anti-HIV Drugs
NCT ID: NCT00002412
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Emivirine
Hydroxyurea
Stavudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Triangle Pharmaceuticals
INDUSTRY
Locations
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Dr Robert Wallace
St. Petersburg, Florida, United States
Countries
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Other Identifiers
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MKC-305
Identifier Type: -
Identifier Source: secondary_id
292C
Identifier Type: -
Identifier Source: org_study_id