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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind Study of MKC-442 Combined With Stavudine, Didanosine, and Hydroxyurea in HIV-Infected Patients Who Are Protease Inhibitor Experienced and Non-Nucleoside Reverse Transcriptase Inhibitor Naive

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Emivirine
* Drug: Hydroxyurea
* Drug: Stavudine
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Emivirine|nan|
|Drug: Hydroxyurea|nan|
|Drug: Stavudine|nan|
|Drug: Didanosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Didanosine, Drug Therapy, Combination, Stavudine, Hydroxyurea, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, MKC 442