Expired Study
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Whitehouse Station, New Jersey 08889


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00002351


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Whitehouse Station, New Jersey 08889
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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