A Study of L-735,524 in HIV-Positive Children and Adolescents
Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001
Trial Information
Current as of May 19, 2025
Completed
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.
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Whitehouse Station, New Jersey, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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