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

Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001

Keywords

ClinConnect 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.

Gender

ALL

Eligibility 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.