A Study of L-735,524 in HIV-Positive Children and Adolescents

Study Overview
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Brief Summary
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To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the plasma concentration profile after the initial dose with data from a historical group of adults. To obtain preliminary data on antiviral activity of MK-639.

Detailed Description
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Patients receive MK-639 for 14 and one-third days. Repeat plasma samples are collected up to 8 hours following the first and last dose. Urine samples are collected on days 1 and 5.

Official Title
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An Open-Labeled, Multiple Dose, Multicenter Study to Investigate the Safety, Tolerability, and Plasma Concentration Profile of L-735,524 Capsules in HIV-Seropositive Older Children and Adolescent Patients

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Indinavir sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: HIV positivity. No active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina. Body surface area at least 1.0 sqm. Consent of parent or guardian. Prior Medication: Allowed: Aerosolized pentamidine. Topical antifungals. TMP / SMX. AZT. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant hepatic disease including HBsAg or hepatitis C positivity. Significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder. Significant cardiac disease including dysrhythmia or cardiomyopathy. Significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results. Has a social situation that may interfere with study participation. Concurrent Medication: Excluded: Oral contraceptives. Patients with the following prior conditions are excluded: History of serious allergic drug reactions. History of significant cardiac disease. Participation on another clinical trial within the past 4 weeks. Donated blood within the past 4 weeks. Prior Medication: Excluded within the past 4 weeks: Hematopoietic growth factors. Excluded within the past 2 weeks: Antiretroviral agent other than zidovudine. Oral contraceptives. Prophylaxis for opportunistic infections, other than aerosolized pentamidine, topical antifungals, and TMP/SMX. Any other medication unless approved by Merck clinical monitor. Current illicit drug use.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|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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Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors, Indinavir